Malfunction S205
Contents
1. URGENT DEVICE FIELD CORRECTION Symbiq One Channel Infuser List Number 16026 Symbiq Two Channel Infuser List Number 16027 Malfunction S205 Backup Battery Failure February 8th 2013 Dear Healthcare Professional Hospira Healthcare Corporation is issuing this letter because we have received reports of Malfunction S205 Backup Battery Failure alarms in some Symbiq v3 13 pumps This error is related to an installation issue with components on some of the Power Supplier Controller PSC Boards In those cases where components on the PSC board were not installed correctly the backup battery coin cell discharges and cannot be recharged Devices experiencing this issue will display a visual warning S205 Malfunction and an audible alarm will be triggered The coin cell battery powers the backup buzzer alarm and will need to be charged or replaced The visual warning will be displayed on the user interface screen until the issue is corrected There are no other situations or events that will cause a S205 alarm to be displayed It is highly unlikely that this issue would cause any harm to a patient The S205 alarm does not stop the pump or interfere with the infusion The coin cell battery is not used to power the device during infusion The coin cell battery is only used to power the device s secondary buzzer to inform the user that the power level no low AC power or depleted main battery has dropped below the level required to opera2. m or product complaints Hospira Clinical Support 1 866 488 6088 Option 4 mail For ClinSupport hospira com Clinical Assistance Hospira is committed to providing our customers with the highest level of service and product quality We appreciate your cooperation and we regret any inconvenience this action may cause Sincerely Vins Rania Al Ammar Regional Director Commercial Quality 2 of 2
3. te the infuser Recommended actions If an S205 alarm is observed perform the following steps to determine if it is caused by this issue 1 Charge the backup battery for 20 hours by plugging the pump into an AC power outlet as defined in the Symbiq Technical Service Manual 2 At the completion of the charging cycle perform a PVT test If the test indicates that the S205 failure is still present the device may be impacted by this issue 3 Although this issue is unlikely to cause any harm to a patient Hospira recommends that your facility remove the device from service and contact Hospira Canadian Service Center at 1 866 488 6088 Option 5 to report the issue and to arrange to have your device repaired Hospira Healthcare Corporation Corporation de soins de la sant Hospira 1111 boul Dr Frederick Philips Blvd 6 tage Suite 600 Saint Laurent Qu bec Canada H4M 2X6 1 of 2 Please complete the attached reply form and return it via fax to the number on the form even if you do not currently have a Symbiq Infuser If you have further distributed the Symbiq Infusers please notify your accounts who may have received these infusers from you and ask them to complete the reply form For further inquiries please contact Hospira using the information provided below Hospira Contact Contact Information Areas of Support Canadian Service Center 1 866 488 6088 Option 5 To report adverse events CanadaPumpSupport hospira co
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