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 Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This freedom ac 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 green connector on the freedom a/c power supply would not connect to the green receptacle on the freedom power adaptor.The syncardia clinical support specialist reported that he tried to connect the freedom a/c power supply to the freedom power adaptor with the same result.This alleged failure mode poses a low risk to a patient because this issue was observed when the freedom a/c power supply was not in use by a patient.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up 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 green connector on the freedom ac power supply would not connect to the green receptacle on the freedom power adaptor.The syncardia clinical support specialist reported that he tried to connect the freedom ac power supply to the freedom power adaptor with the same result.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the ac power supply revealed that the connector cover was not in the correct orientation.This is the root cause of the customer-reported inability to connect the ac power supply to a freedom power adaptor.It is likely that the cable connector cover was installed incorrectly at syncardia during incoming inspection.During incoming inspection at syncardia, inspectors perform a verification to ensure the connector's interior threads are properly mated with adhesive.The verification requires inspectors to remove the connector cover.Incoming inspection requirements were revised to clearly identify and verify the correct alignment of the connector cover.This failure mode poses a low risk to a patient because the freedom hospital 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 an additional hospital ac power supply and multiple rechargeable freedom onboard batteries.The hospital 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.The freedom ac power supply was reassembled, serviced, and passed all functional and performance testing before being placed into 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 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: 5141966
• MDR Text Key: 28379087
• Report Number: 3003761017-2015-00352
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• 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: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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