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

Catalog Number 293001-001

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2014

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) (mfr report #3003761017-2014-00300); and companion external battery s/n (b)(4).The customer reported that the companion 2 driver displayed "external battery alarms" when both batteries were inserted in the driver while it was connected to the wall power.The customer also reported that the companion external batteries were removed from the companion 2 driver and cleaned with canned air, but the battery alarms did not resolve.

Manufacturer Narrative

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

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: companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00300); and companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00301).The customer reported that the companion 2 driver displayed "external battery alarms" when both batteries were inserted in the driver while it was connected to the wall power.The customer also reported that the companion external batteries were removed from the companion 2 driver and cleaned with canned air, but the battery alarms did not resolve.Companion external battery s/n (b)(4) was returned to syncardia for evaluation.Review of the incoming inspection records for the external battery did not reveal any abnormalities and confirmed the battery was manufactured according to specifications, and the battery met all test acceptance criteria.Inspection of the units did not reveal any abnormalities, however, the battery was observed to be beyond the expiration date at the time of the customer reported issue.The battery expired october 2014.Review of the battery's electronic data and status did not exhibit any abnormalities.Evaluation of the battery revealed no abnormalities.The battery was found to function as intended.All attempts to duplicate the customer reported issue were unsuccessful.Although no root cause for the intermittent alarms could be identified, it is likely that the age of the battery could have been a contributing factor.The companion external battery was not in patient use at the time of the customer reported issue.Companion external battery failures present a low risk to a patient because the companion 2 driver system utilizes multiple power sources including replaceable external batteries, an internal emergency battery, and the ability to connect to ac wall power.Companion external battery s/n (b)(4) will be 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: 4368414
• MDR Text Key: 5289010
• Report Number: 3003761017-2014-00301
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• 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: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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