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

Catalog Number 295400-002

Device Problems Failure to Disconnect (2541); Connection Problem (2900); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

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

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This (b)(6) hospital ac power supply eu was not in patient use.The (b)(6) hospital ac power supply eu is a component that enables the (b)(6) driver to be plugged into an external power source.The customer reported that the hospital ac power supply eu was very difficult to connect to a (b)(6) power adaptor.The customer also reported that once the hospital ac power supply eu was connected, the green led did not illuminate.The customer also reported that it was also very difficult to disconnect the hospital ac power supply eu from the power adaptor.The customer also reported that it was also difficult to connect the hospital ac power supply eu to a battery charger.This alleged failure mode poses a low risk to a patient because this issue was observed when the (b)(6) hospital ac power supply eu was not in use by a patient.In addition, the reported issue would not prevent a (b)(6) driver from performing its life-sustaining functions.The (b)(6) driver has a redundant power source of onboard batteries.The (b)(6) hospital ac power supply eu 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 (b)(6) hospital ac power supply eu was not in patient use.The (b)(6) hospital ac power supply eu is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the hospital ac power supply eu was very difficult to connect to a freedom power adaptor.The customer also reported that once the hospital ac power supply eu was connected, the green led did not illuminate.The customer also reported that it was also very difficult to disconnect the hospital ac power supply eu from the power adaptor.The customer also reported that it was also difficult to connect the hospital ac power supply eu to a battery charger.The hospital ac power supply eu was returned to syncardia for evaluation.Visual inspection revealed that the cable connector cover was not in the correct orientation.This prevented the hospital ac power supply eu from making a proper connection to provide power to a freedom power adaptor or battery charger.The 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 ac power supply cable was reassembed, the hospital ac power supply eu passed all required functional testing.The root cause for the observed issue was the incorrect orientation of the connector cover on the (b)(6) hospital ac power supply eu, which may result from processes at the component supplier or syncardia.Syncardia has implemented process controls to identify this issue prior to release of freedom ac power supplies to finished goods and to eliminate the potential for recurrence.The occurrence rate for this issue is extremely low and there is no impact to the patient.The incorrect orientation of the connector cover is immediately identifiable by hospital personnel when preparing the freedom driver for patient use per section 7.5 of f-900012, freedom driver system operator manual.The freedom driver system includes multiple power sources and power supply accessories such that operation of the driver is not impacted by this issue.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: 5642599
• MDR Text Key: 46168253
• Report Number: 3003761017-2016-00191
• 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: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295400-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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