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

Catalog Number 295050-001

Device Problems Loose or Intermittent Connection (1371); Device Stops Intermittently (1599); Device Inoperable (1663); Power Problem (3010)

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

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

Ce 3036 initial.

Event Description

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 the freedom ac power supply has intermittent functioning loose connection.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.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

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 the freedom ac power supply has intermittent functioning loose connection.The customer also reported that the freedom ac power supply was switched without patient impact.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed a missing rubber foot and clear connector o-ring.The missing rubber foot and connector o-ring are not related to the customer-reported issue.The ac power supply was evaluated and met all function and electrical requirements.There was no evidence of a loose connection fit or interruption in performance when it was connected to a freedom power adaptor during the evaluation.The customer-reported issue could not be confirmed; therefore, the root cause could not be determined.Despite the customer-reported issue, risk to the patient was low because the freedom driver would not have been prevented 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 missing rubber foot and missing o-ring, 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: 5226076
• MDR Text Key: 31572220
• Report Number: 3003761017-2015-00387
• 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,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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
• Patient Age: 45 YR