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

Catalog Number 295050-001

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/12/2015

Event Type  malfunction  

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 drive to be plugged into an external power source.The customer reported that it was difficult to connect the freedom a/c power supply to the freedom power adaptor during a system check.The customer also reported that when the freedom a/c power supply was connected to the freedom power adaptor, there was no indication of a connection to an external power source.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 ac power supply was not in patient use.The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that it was difficult to connect the freedom ac power supply to the freedom power adaptor during a system check.The customer also reported that when the freedom ac power supply was connected to the freedom power adaptor, there was no indication of a connection to an external power source.Freedom ac power supply s/n (b)(4) 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 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.Incoming inspection requirements are in the process of being improved, to clearly identify the correct removal and replacement of the connector cover.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 Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4484384
• MDR Text Key: 5348944
• Report Number: 3003761017-2015-00024
• 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
• Report Date: 01/12/2015

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: Other Health Care Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 01/29/2015
• 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