MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM A/C POWER SUPPLY

Catalog Number 295050-001

Device Problems Connection Problem (2900); Power Problem (3010)

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

Event Date 11/21/2014

Event Type  malfunction  

Event Description

The freedom a/c power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the plug on a pt's freedom a/c power supply would not connect to the freedom power adaptor.The pt was provided with a replacement a/c power supply.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because it did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

The ac power supply cable was disassembled, the connector key slot was aligned with the connector cover key tab and the correct mating configuration was obtained.After the ac power supply cable was reassembled, the ac power supply passed all final performance testing.This failure mode poses a low risk to a pt because the freedom ac power supply was not in use by a pt at the time of the customer-reported issue.Pts are provided with two freedom ac power supplies.In addition, it would not prevent a freedom driver from performing its life-sustaining functions.The freedom driver is equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and a car charger.The freedom ac power supply met all required acceptance criteria and the unit will be 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.

Event Description

The ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed that the cable connector cover was installed backwards.This is the root cause of the customer-reported inability to connect the ac power supply to a freedom power adapter.It is likely that the cable connector cover was installed incorrectly.

• Brand Name: SYNCARDIA FREEDOM A/C POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4359950
• MDR Text Key: 5112294
• Report Number: 3003761017-2014-00288
• 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: 11/24/2014

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: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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