MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM ONBOARD BATTERY

Catalog Number 295025-001

Device Problems Premature Discharge of Battery (1057); Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

The freedom onboard battery will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

Event Description

The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: freedom onboard battery s/n (b)(4) (mfr report #3003761017-2015-00225).The customer reported that the pt said the freedom onboard battery had a low capacity.The customer also reported that the freedom onboard battery was exchanged for a new freedom onboard battery without any pt impact.

Manufacturer Narrative

Follow-up 1 (1 of 2) - sn (b)(4).

Event Description

The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00224) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00225).The customer reported that the patient said the freedom onboard battery had a low capacity.The customer also reported that the freedom onboard battery was exchanged for a new freedom onboard battery without any patient impact.Freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation.The onboard battery s/n (b)(4) successfully passed visual inspections, and the battery was within the useful life period at the time of the customer-reported issue.During investigation evaluation, onboard battery s/n (b)(4) could not communicate with the smbus (system management bus) reader and, therefore, was determined to be inoperative.The smbus is the communication protocol used to communicate with the freedom onboard batteries.The root cause for onboard battery s/n (b)(4) being inoperative could not be determined without further destructive disassembly.The freedom onboard battery is designed as a disposable unit, and no further investigation was conducted.Risk to the patient was low because it would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external wall power, and patients are provided with several onboard batteries.Additionally, the patient is provided with additional onboard batteries.Because onboard battery s/n (b)(4) was inoperative, the battery was 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 FREEDOM ONBOARD BATTERY
• Type of Device: BATTERY
• 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: 4935628
• MDR Text Key: 22409968
• Report Number: 3003761017-2015-00224
• 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: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295025-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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