Field Safety Notice
Contents
1. Field Safety Notice Technical Bulletin Q CORE MEDICAL SAPPHIRE INFUSION PUMP Sapphire Multi Therapy Pump Hospira L N xxxxxx Q Core P N xxxxxx Sapphire Epidural Pump Hospira L N xxxxxx Q Core P N xxxxxx Action Taken by the Company To address this issue Q Core Medical is providing an addendum to the User Manual attached to this notification to assist customers in i identifying whether the catheter utilised may cause over delivery ii better understanding the effect of back pressure and catheter size on the accuracy of the delivered volume iil translating the catheter s back pressure to the degree of flow deviation that can be expected and iv contacting Q Core Support aqcore com to determine if and to what extent specific catheter oump combinations are susceptible to over delivery Future versions of the User Manual will incorporate the information contained in the addendum Actions to be Taken by the User 1 Inform Inform the healthcare professionals in your organisation about this notification and provide them with a copy of the notification 2 Add the Addendum to your User Manual Photocopy a sufficient number of the attached Addendum and add a copy to each Sapphire Infusion Pump User Manual in your healthcare facility 3 Adjust bolus and basal flow rates If a catheter size smaller than 20 gauge is used and over delivery is experienced during utilisation of Epidural mode with patient bolus A Restric2. VTBI lower infusion rate and higher backpressure In Epidural intermittent mode bolus rate is set to 125 mL h In PCEA mode bolus rate can be configured to 125 mL h or 200mL h before starting infusion for details refer to Epidural Mode Options Menus on Chapter 7 For details about the impact of different back pressures on pump delivery caused by different catheter sizes when used in Epidural mode refer to pump accuracy in Chapter 12 Changes to Chapter 12 Technical Specifications clause Pump Accuracy The following section replaces the entire section titled Pump Accuracy The updated text is marked in bold The following graphs and curves were derived from the pump accuracy testing procedures described in the IEC60601 2 24 standard Testing was performed under normal conditions specified in IEC60601 2 24 standard at room temperature 25 C 72 F Normal conditions to ensure optimal accuracy of 2 5 e Fluid level should be 50 cm above the pump e No back pressure due to catheter size or difference in height of pump and infusion site e Room temperature 25 C e Barometric pressure of sea level altitude 101 kPa e IV medication with water like fluid characteristics D QCORE 29 Yad Haruzim St PO Box 8639 Netanya 4250529 ISRAEL medical Tel 972 73 2388888 Fax 972 73 2388800 info qcore com www qcore com ADDENDUM USER MANUAL SAPPHIRE MULTI THERAPY AND DEDICATED INFUSION P
3. Field Safety Notice Technical Bulletin Q CORE MEDICAL SAPPHIRE INFUSION PUMP Sapphire Multi Therapy Pump Hospira L N xxxxxx Q Core P N xxxxxx Sapphire Epidural Pump Hospira L N xxxxxx Q Core P N xxxxxx 16 July 2015 Dear Healthcare Professional and Valuable Customer Q Core Medical has received complaints from a few customers that when using Epidural mode with patient bolus the amount of medication delivered may be greater than programmed In the Sapphire pump as in all infusion systems external factors may cause fluctuations in flow rate accuracy Investigation of these complaints determined that the catheters used in these cases were of a gauge smaller than that used for the Sapphire pump flow accuracy calibration The Sapphire Infusion System is distributed by Hospira or their distributors in your country Cause The Sapphire pump is calibrated to operate within its accuracy specifications when used with a Reference Catheter that provides a back pressure of 0 32 bar at 125 mL h bolus delivery rate and 0 57 bar at 200 mL h bolus delivery rate Using catheters that create a lower back pressure may result in over delivery during Epidural treatments with patient bolus The actual deviations that occurred during clinical use with either flow rate as reported in the complaints were within the range of 0 5 8 8 over delivery This deviation in accuracy may occur only when all of the following conditions are concurrently fulfille
4. UMPS Epidural Mode the operating conditions to ensure optimal accuracy of 2 5 while utilizing an Epidural catheter are e Use of catheter that creates a back pressure of 0 32 bar 4 35 PSI at 125 mL h and 0 57 bar 8 26 PSI at 200 mL h This back pressure is typical for 20 gauge catheters that usually have an internal diameter of 0 45 or 0 46 mm e Catheters with gauge size smaller than 20 may create over delivery and catheters with gauge size larger than 20 may create under delivery In the Sapphire pump as in all infusion systems external factors may cause fluctuations in rate accuracy Conditions that can cause flow fluctuations include e Position of the infusion container height any deviation from 50 cm above the pump e Fluid characteristics that deviate from water like characteristics such as density viscosity and homogeneity e Positive and negative pressure including back pressure e Environmental temperature above or below 25 C and barometric pressure above or below 101kPa For example e A change of 25 cm in the fluid level above the pump may result in deviation in accuracy of 1 e A change of 0 05 bar in back pressure may result in deviation in accuracy of 3 e Using sets with PAV may result in deviation in accuracy of 6 Note 1 In Epidural mode the inner diameter of the catheter as well as the tubing length may create back pressure that impacts the accuracy of the pump and to a lesser
5. ance is required in determining whether the catheter used may result in over delivery during delivery with Epidural mode with a bolus or in calculating the impact that the catheter may have in over delivery please contact support qcore com or tick this box O DB QCORE 29 Yad Haruzim St RO Box 8639 Netanya 4250529 ISRAEL medical Tel 972 73 2388888 Fax 972 73 2388800 info qcore com www qcore com ADDENDUM USER MANUAL SAPPHIRE MULTI THERAPY AND DEDICATED INFUSION PUMPS Changes to Chapter 5 Using the Infusion Modes clause Epidural Mode The following replaces the section between the title Epidural Mode and the warning Epidural Mode Safety Precautions The updated text is marked in bold This mode enables the pump to deliver epidural infusions Epidural administration is limited to short term infusions up to 96 hours using indwelling catheters specifically identified for epidural drug delivery In Epidural infusion mode the pump can operate in either of the following sub modes e PCEA Patient Controlled Epidural Analgesia Delivers epidural boluses either alone or in addition to a basal preset rate Alternatively only a basal infusion without boluses can be programmed e Intermittent Epidural Delivers epidural infusions at intermittent pre set intervals The features of the Epidural mode are designed to accommodate the special requirements of an epidural infusion such as lower
6. d 1 Epidural mode Running an infusion in the Epidural delivery mode 2 Bolus The patient is given a patient bolus 3 Catheter selection Using a catheter with a back pressure that is lower than the back pressure of the Reference Catheter The extent of deviation in volume delivered is highly dependent on the catheter selected together with the limitations imposed by the pump and the parameters set for the Epidural treatments Currently the Q Core Medical User Manual does not include the parameters of the Reference Catheter to allow precise correlation between the catheter dimensions the back pressure and the deviation in flow that the catheter may cause Risk to Health No patient injuries or deaths have been reported as a result of this issue Although Epidural drugs may lead to adverse effects such as respiratory depression Q Core s investigation determined that there are no increased risks to health as a result of the over deliveries reported Smiths Medical Portex catheter 20 G length 915 mm product code 100 382 1 18 24 35 PSI 3 8 26 PSI 4 Using a catheter with back pressure higher than the Q Core Medical Reference Catheter while using Epidural mode with patient bolus leads to under delivery There have been no complaints regarding under delivery B QCOI E 29 Yad Haruzim St RO Box 8639 Netanya 4250529 ISRAEL medical 73 2388888 Fax 972 73 2388800 info qcore com www qcore com
7. extent so may the fluid viscosity Under delivery or over delivery that may occur due to a change in catheter size may be estimated based on the following formulas deviation at 125 back pressure of catheter bar at 125 aa 0 32 bar 0 05 Ibar bar deviation at 200 back pressure of catheter bar at 200 7 0 57 bar 0 05 Ibar bar For example if the backpressure for the catheter in use is 0 2 bar 2 9 PSI at 125mL h the resulting deviation 7 2 BD QCOI tE 29 Yad Haruzim St P O Box 8639 Netanya 4250529 ISRAEL medical Tel 972 73 2388888 Fax 972 73 2388800 info qcore com www qcore com ADDENDUM USER MANUAL SAPPHIRE MULTI THERAPY AND DEDICATED INFUSION PUMPS If the back pressure of the catheter used is unknown please consult the set manufacturer You may also contact Q Core Medical Support at support qcore com and Q Core will either measure or calculate the back pressure and or deviation according to the provided parameters Practical recommendations If using a catheter size smaller than 20 gauge and over delivery is experienced during Epidural mode with patient bolus A Restrict the programmed flow rate for bolus delivery to 125 mL h not 200 mL h If the treatment is programmed to bolus only infusion the highest deviation that can occur is 12 at 125 mL h And B When clinically applicable use a basal rate of at least 1 mL h Any basal rate that is larger
8. t the programmed flow rate for bolus delivery to 125 mL h not 200 mL h lf the treatment is programmed to bolus only infusion the highest deviation that can occur is 12 at 125 mL h And B When clinically applicable use a basal rate of at least 1 mL h Any basal rate that is larger than zero will reduce the amount of over delivery Note Over delivery can be further reduced or eliminated by 1 Restricting the number of boluses administered and or 2 Restricting the volume infused during boluses and or 3 Programming a basal flow rate over 1 mL h 4 For optimal flow accuracy use a 20 gauge Epidural catheter where suitable 4 Complete the Customer Response Form A Complete the attached response form B Return the form to the Q Core service department via the e mail address included on the form Please do so even if you do not have an affected product B QCOI E 29 Yad Haruzim St RO Box 8639 Netanya 4250529 ISRAEL 9 LJ medical Tel 972 73 2388888 Fax 972 73 2388800 infoG qcore com www qcore com Field Safety Notice Technical Bulletin Q CORE MEDICAL SAPPHIRE INFUSION PUMP Sapphire Multi Therapy Pump Hospira L N xxxxxx Q Core P N xxxxxx Sapphire Epidural Pump Hospira L N xxxxxx Q Core P N xxxxxx Enquiries and Support Catheter Enquiries If further assistance is required to determine i whether the catheter you are using may result in over delivery during Epidural infusion
9. than zero will reduce the over delivery Note Over delivery can be further reduced or eliminated by 1 Restricting the number of boluses administered and or 2 Restricting the volume infused during boluses and or 3 Programming a basal flow rate to more than 1 mL h 4 For optimal flow accuracy use a 20 gauge Epidural catheter where suitable Note 2 When using accessories where the container height deviates from 50 cm above the pump there may be deviations in pump accuracy e g PCA Lockboxes and the Homecare Large Backpack QCORE 29 Yad Haruzim St PO Box 8639 Netanya 4250529 ISRAEL medical Tel 972 73 2388888 Fax 972 73 2388800 info qcore com www qcore com
10. with a patient bolus or ii the estimated effect that the catheter may have in over delivery please contact support qcore com or mark the appropriate box in the attached customer response form For other enquiries please contact Hospira using the information provided below Hospira Contact Contact information XXXXXX XXXXXX Tally Eitan President Q Core Medical Ltd BD QCORE 29 Yad Haruzim St P O Box 8639 Netanya 4250529 ISRAEL medical Tel 972 73 2388888 Fax 972 73 2388800 info qcore com www qcore com Field Safety Notice Technical Bulletin Q CORE MEDICAL SAPPHIRE INFUSION PUMP Sapphire Multi Therapy Pump Hospira L N xxxxxx Q Core P N xxxxxx Sapphire Epidural Pump Hospira L N xxxxxx Q Core P N xxxxxx RESPONSE IS REQUIRED Please e mail the completed form to QCore6646 stericycle com Customer Information Business Name Hospira Customer Number if applicable Address Town City County Region Postcode Contact Name Phone E mail Address Completed by Printed Name Signature Date Actions to be taken For Hospitals gt have received and read the letter dated 16 July 2015 and have provided a copy to each of the users in the facility YESO NOO If NO state the reason gt have copied and attached the Addendum to each Sapphire Infusion Pump User Manual in my healthcare facility YESO NOO If NO provide the date when this will be completed If further assist
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