MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY

Catalog Number 295050-001

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Electrical Power Problem (2925); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

The freedom a/c power supply was not in patient use.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 freedom a/c power supply had a broken plug and would not function properly.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom a/c power supply was not in patient use.In addition, the freedom driver has a redundant power source of onboard batteries.

Manufacturer Narrative

The freedom a/c power supply will be returned to syncardia for evaluation.The results of the investigation will provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This freedom a/c power supply was not in patient use.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 freedom a/c power supply had a broken plug and would not function properly.Freedom 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 adaptor.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 testing requirements.This issue was identified to be isolated to one lot that was inspected at syncardia.In response to an unrelated issue regarding power supply connectors coming apart, the inspector performed a verification to ensure the connectors' interior threads were properly mated with adhesive.The verification required the inspector to remove the connector covers.Therefore, it is possible that the cable connector cover was installed incorrectly during reassembly at syncardia during incoming inspection.Incoming inspection requirements were improved to clearly identify the correct removal and replacement of the connector cover.This failure mode poses a low risk to a patient because the freedom ac power supply was not in use by a patient at the time of the customer-reported issue.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.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 AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): 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: 4484366
• MDR Text Key: 16172729
• Report Number: 3003761017-2015-00025
• 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,Followup
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• 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: 01/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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