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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM HOME AC POWER SUPPLY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM HOME AC POWER SUPPLY Back to Search Results
Catalog Number 295600-001
Device Problems Electrical /Electronic Property Problem (1198); Loss of Power (1475); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) 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 patient stated that this freedom ac power supply and the cable linking the ac power supply to his freedom driver seemed to be abnormally hot, so he switched to his backup ac power supply.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the patient's 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
Part number was corrected from 295050-001 to 295600-001.(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 patient stated that this freedom home ac power supply and the cable linking the ac power supply to his freedom driver seemed to be abnormally hot, so he switched to his backup ac power supply.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.The home ac power supply was returned to syncardia for evaluation.Visual inspection of the exterior revealed no abnormalities.The home ac power supply was tested, and the unit met all functional and electrical test acceptance criteria.Additional electrical load testing at a nominal 6.5 amps resulted in a slight elevation in connector temperature to the touch.Disassembly and internal visual inspection of the connector designed to mate the home ac power supply to the freedom power supply revealed solder tinning of the wires before crimping and evidence of the pre-tinned wires not being fully inserted into the crimp socket at the time the crimp was made.This workmanship issue is the root cause of the reported temperature increase.The home ac power supply will be returned to the supplier for additional evaluation and corrective action.This 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 has redundant power sources, including multiple rechargeable onboard batteries and a car charger, and patients are provided with multiple ac power supplies.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.
 
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Brand Name
SYNCARDIA FREEDOM HOME 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 Key5627230
MDR Text Key45102624
Report Number3003761017-2016-00164
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number295600-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age55 YR
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