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

Catalog Number 295050-001

Device Problems Difficult to Insert (1316); Connection Problem (2900); Device Operates Differently Than Expected (2913); Power Problem (3010)

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

Event Date 04/29/2015

Event Type  malfunction  

Event Description

This freedom a/c power supply was not in patient use.The customer reported that the connector of the freedom ac power supply could not be correctly inserted into the freedom power adaptor or the freedom battery charger.The customer also reported that the freedom a/c power supply did not illuminate when connected to wall power and the freedom power adaptor.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, it 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 a/c power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

This freedom ac power supply was not in patient use.The customer reported that the connector of the freedom ac power supply could not be correctly inserted into the freedom power adaptor or the freedom battery charger.The customer also reported that the freedom ac power supply does did not illuminate when connected to wall power and the freedom power adaptor.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed the strain relief for the ac power cord was damaged.This is consistent with the result of normal use.Visual inspection of the freedom ac power supply also revealed the output power connector terminals were misaligned, which caused the difficulty to connect the freedom ac power supply into the freedom power adaptor or battery charger receptacles, as reported by the customer.Visual inspection of the freedom ac power supply also revealed the output power connector housing was cracked.This is consistent with the result of applied force from attempting to make a connection with the misaligned connector terminals.The root cause of the misaligned connector terminals could not be determined by syncardia or the manufacturer.This is the first occurrence of this specific issue.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, 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 backup ac power supply.Because of the damaged strain relief, misaligned connector terminals, and cracked connector, freedom ac power supply s/n (b)(4) was taken out of service.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: 4812370
• MDR Text Key: 5924439
• Report Number: 3003761017-2015-00160
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• 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: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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