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

Catalog Number 293001-001

Device Problems Low Battery (2584); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under four separate medical device reports: (1) companion external li-battery pack (b)(4) (mfr report # 3003761017-2015-00279, (2) companion external li-battery pack (b)(4) (mfr report # 3003761017-2015-00280), (3) companion external li-battery pack (b)(4) (mfr report # 3003761017-2015-00281), and (4) companion external li-battery pack (b)(4) (mfr report # 3003761017-2015-00282).The customer reported that the companion external batteries in an unplugged companion 2 driver were losing charge quicker than what was displayed on the battery gauge.The customer also reported that all four external batteries were tried on the same driver with the same result.The customer also reported that the patient subsequently switched to the backup companion external batteries without any adverse patient impact.This alleged failure mode poses a low risk to the patient since the low battery did 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 batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under four separate medical device reports: companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00279, companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00280), companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00281), and companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00282).The customer reported that the companion external batteries in an unplugged companion 2 driver were losing charge quicker than what was displayed on the battery gauge.The customer also reported that all four external batteries were tried on the same driver with the same result.The customer also reported that the patient subsequently switched to the backup companion external batteries without any adverse patient impact.Companion external battery s/n 40163 was returned to syncardia for evaluation.Visual inspection of the external battery revealed no abnormalities.The external battery was connected to battery evaluation software, and review of the data revealed that the external battery was functional, and no permanent faults were logged.In addition, the state of charge values were consistent with the gas gauge displayed values.The external battery was functionally tested and passed all test requirements.In addition, the external battery met the minimum required discharge duration of 30 minutes.The customer-reported issue could not be reproduced during testing, and there was no evidence of a device malfunction.The companion 2 driver system operator manual (c2-900005), at chapter 13, "power management," advises users that when fully charged, each companion external battery provides a minimum of 30 minutes of support.Two fully charged external batteries provide a minimum of 60 minutes of support.External battery support may vary based on driver settings.After disconnecting from wall power, the companion 2 driver display will take approximately one minute to update the estimated battery support time based on driver settings.The reported issue posed a low risk to the patient because it did 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.In addition, all power sources are continually monitored by the companion 2 driver, with audible and visual alarms provided to annunciate any potential issues with the driver power sources.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: 5058321
• MDR Text Key: 25795416
• Report Number: 3003761017-2015-00279
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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 Age: 30 YR