MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

Catalog Number 293001-001

Device Problems Battery Problem (2885); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

This companion external battery was not in use by a pt.The customer reported that the companion external battery was not recognized when placed into a companion 2 driver during a system check.This alleged failure mode poses a low risk to a pt because the issue was observed when the companion external battery was not in pt use.In addition, it would not prevent a companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power source of an internal, emergency battery and wall power.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4) follow-up report 1.

Event Description

This companion external battery was not in use by a patient.The customer reported that the companion external battery was not recognized when placed into a companion 2 driver during a system check.The companion external battery s/n (b)(4) was returned to syncardia for evaluation.Physical inspection of the battery revealed no anomalies.The reported fault condition was verified by testing; battery s/n (b)(4) did not charge or provide power output.The root cause for the battery's permanently disabled output could not be conclusively determined during the investigation.However, analysis of the recorded smbus (system management bus) data indicated that the battery was subjected to a deep discharge event, causing the trigger of cuv (cell under-voltage) / puv (pack under-voltage) flags.Because parameters outside of the internal safety firmware design limits were detected, the battery's input/output functions were permanently disabled.This failure mode poses a low risk to a patient because the companion external battery was not in patient use at the time the issue was observed.In addition, this failure mode would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources which include external wall power and an internal, emergency battery.In addition, all power sources are continually monitored by the companion 2 driver, with audible and visual alarms provided to annunciate any potential issues associated with the driver power sources.This failure mode has been documented previously and investigated by the supplier.The supplier reported that storing a companion external battery in a companion 2 driver without connection to external power for approximately three weeks could result in the battery achieving a deeply discharged state and being disabled by its internal safety circuitry.Companion external battery s/n 40278 was found to be inoperative and was taken out of service.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
• Type of Device: BATTERY PACK
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4766042
• MDR Text Key: 18932156
• Report Number: 3003761017-2015-00151
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor,distributor,forei
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1