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

Catalog Number 293001-001

Device Problem Failure to Charge (1085)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

The reported issue involves 2 companion external batteries that are reported under 2 separate medical device reports: companion external battery sn (b)(4) (mfr rep #3003761017-2015-00202) and companion external battery sn (b)(4) (mfr rep #3003761017-2015-00203).The customer reported that the companion external batteries are providing less charge while supporting a pt.The pt subsequently switched to the backup companion external batteries.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because, the battery issue did not prevent the companion 2 driver from performing its life-sustaining functions.The companion external batteries will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The reported issue involves two companion external batteries that are reported under two separate medical device reports: companion external battery s/n (b)(4) (mfr report # 3003761017-2015-00202) and companion external battery s/n (b)(4) (mfr report # 3003761017-2015-00203).The customer reported that the companion external batteries are providing less charge while supporting a patient.The patient subsequently switched to the backup companion external batteries.There was no reported adverse patient impact.The companion external battery s/n (b)(4) was returned to syncardia for evaluation.The external battery s/n (b)(4) was physically inspected and found to exhibit no physical abnormalities.The external battery (manufactured december 2013) were still within their use life period of four years and six months.The external battery's smbus data was evaluated, and there were no permanent faults or error flags.The smbus data is the smart management bus, used in communicating with companion external batteries.External battery s/n (b)(4) was used to operate a companion 2 driver for a preliminary functional assessment, and there were no low external battery indications.The external battery was tested and the battery passed all sections of the test procedure.The customer-reported issue could not be duplicated during testing.There was no evidence of a device malfunction.The customer-reported issue posed a low risk to the patient because it 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.The companion external battery s/n (b)(4) was returned to finished goods.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: 4865851
• MDR Text Key: 5860099
• Report Number: 3003761017-2015-00202
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

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: Lay User/Patient
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• 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
• Patient Age: 17 YR