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

Catalog Number 293001-001

Device Problems Charging Problem (2892); Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The companion external battery was not supporting a patient.The customer reported that the companion external battery was not holding a charge despite charging the battery for several days and connecting it to different companion 2 drivers.This alleged failure mode poses a low risk to a patient because the issue was observed when the companion external battery was not supporting a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has a redundant, alternate power source of external wall power.The companion external battery will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4) fup 1.Please note that this is a corrected report.There was no reported adverse patient impact.

Event Description

This companion external battery was not in patient use.The customer reported that the companion external battery was not holding a charge despite charging the battery for several days and connecting it to different companion 2 drivers.The external battery was returned to syncardia for evaluation.Visual inspection of the external battery revealed no anomalies.The external battery was connected to battery evaluation software, and it failed to establish smbus (system management bus) communication, indicating that the external battery was fully depleted and in "cutoff" mode, or it had been disconnected by safety circuitry.The external battery was attached to an external power source, and it successfully established smbus communication.Review of the data revealed that the battery exhibited a "safety over charge current permanent fault (socc pf)," that occurred while the battery was in pre-charge low voltage recovery mode.The socc pf caused the battery's internal safety circuitry to permanently disable the battery.The investigation determined that the root cause for the reported issue was that the external battery was likely subjected to one or more deep discharge events, followed by a prolonged period of inactivity in the discharged state.When the battery was put into the charge state, its safety circuitry disabled its output for exceeding firmware safety limits.This was confirmed by testing, as the external battery would not charge or provide power output.The external battery was taken out of service.This failure mode posed a low risk to a patient because the issue was observed when the companion external battery was not in patient use.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external wall power and an internal, emergency battery.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: 5385114
• MDR Text Key: 37007924
• Report Number: 3003761017-2016-00019
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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
• Patient Outcome(s): Disability