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

Catalog Number 293001-001

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2014

Event Type  malfunction  

Event Description

This companion external battery was not in use by a patient.The reported issue involves syncardia companion external batteries and are reported under two separate medical device reports: companion external battery s/n (b)(4); and companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00325).This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external batteries were not in patient use.In addition, this alleged failure mode would not prevent a companion 2 driver from performing its life-sustaining functions.The companion 2 driver has multiple power sources of external wall power, external batteries and an internal emergency battery.

Manufacturer Narrative

The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This companion external battery was not in use by a patient.The reported issue involves syncardia companion external batteries and are reported under two separate medical device reports: (1) companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00324); and (2) companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00325).The customer reported that the companion 2 external batteries are "dead" and need to be returned.The companion 2 external batteries were returned to syncardia for evaluation.Review of the external components of companion 2 external battery s/n (b)(4) and s/n (b)(4) did not reveal any abnormalities.Testing of companion 2 external battery s/n (b)(4) revealed that the battery did not display output voltage, did not accept charge current and the gas gauge did not indicate charge when the button was pressed.The failure of the battery to operate during testing confirmed the customer reported issue.The root cause of the inoperable battery is unknown, but the results observed are consistent with the lack of use and charging.Testing of companion 2 external battery s/n (b)(4) revealed that the battery was able to establish communication with testing software when connected to an external power source.During testing, it was observed that the battery was in a state of significant over-discharge.However, once the battery was connected to an external power source, the battery was able to enter into "fast charge" mode and fully recharge.In addition, the battery sat for an additional 48 hour rest period.Following the rest period, the battery was verified to have retained the full state of charge and no self-discharge condition existed.The root cause for the customer reported experience is that the cells of companion 2 external battery s/n (b)(4) were in a state of over-discharge and would not enter into "fast charge" mode as required by companion 2 driver firmware.Companion battery s/n (b)(4) was taken out of service.Companion battery s/n (b)(4) was serviced and passed all final performance testing.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external batteries were not in patient use.In addition, this alleged failure mode would not prevent a companion 2 driver from performing its life-sustaining functions.The companion 2 driver has multiple power sources of external wall power, external batteries and an internal emergency battery.This issue will continue to 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 (Section G): 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: 4380567
• MDR Text Key: 5117017
• Report Number: 3003761017-2014-00324
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign,hea
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• 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: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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