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

Catalog Number 295050-001

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2014

Event Type  malfunction  

Event Description

The freedom a/c power supply was not in use by a pt.The freedom a/c power supply is a component that enables the freedom driver to be plugged into an external power source.A syncardia customer service specialist 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 the issue was observed when the freedom a/c power supply was not in pt use.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

(b)(4).

Event Description

The freedom ac power supply was not in use by a patient.The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.A syncardia clinical support specialist reported that the connector on the ac power supply would not fit into the power adaptor.Visual inspection of the freedom ac power supply revealed the output power connector terminals were misaligned.This is the root cause of the customer reported issue, which prevented the ac power supply from connecting well with the freedom power adaptor.The cause of the misaligned connector terminals is unknown; however, it is likely that this occured in the manufacturing process.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.The freedom ac power supply was taken out of service.

• Brand Name: 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: 4359958
• MDR Text Key: 5111732
• Report Number: 3003761017-2014-00289
• 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: Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• 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: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• 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