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)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2015

Event Type  malfunction  

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 syncardia clinical support specialist reported that the green connector of the freedom ac power supply was difficult to insert and does not securely connect into the freedom power adaptor.This alleged failure mode poses a low risk to a patient because this issue was observed when the freedom ac 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).Please note that this is a corrected report.The initial reporter was changed from (b)(6) at syncardia, to (b)(6).

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 syncardia clinical support specialist reported that the green connector of the freedom ac power supply was difficult to insert and does not securely connect into the freedom power adaptor.The hospital freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom hospital ac power supply revealed that the cable connector cover was in the incorrect orientation.This is the root cause of the customer-reported hospital ac power supply's inability to connect to a freedom power adaptor and/or battery charger.The customer reported issue is consistent with the result of the cable connector cover being installed incorrectly at syncardia during incoming inspection in accordance with syncardia's incoming inspection requirements.During incoming inspection at syncardia, inspectors perform a verification to ensure that the connector's interior threads are properly mated with adhesive.The verification requires inspectors to remove the connector cover.This issue has been addressed and incoming inspection requirements were improved to clearly identify the correct removal and replacement 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 multiple rechargeable freedom onboard batteries and a backup ac power supply.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.After the hospital ac power supply cable was reassembled, the ac power supply passed all required functional testing.Because the freedom hospital ac power supply met all required acceptance criteria, the unit was returned to inventory.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: 5340197
• MDR Text Key: 35288012
• Report Number: 3003761017-2015-00436
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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: Health Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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