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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY Back to Search Results
Catalog Number 295070-001
Device Problems Device Inoperable (1663); Power Problem (3010)
Patient Problems Fall (1848); Loss of consciousness (2418)
Event Date 09/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00298, (2) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00300), and (3) freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00306).The customer reported that while the patient was getting up to get something to eat, the freedom driver stopped working.The customer also reported that the patient lost consciousness, fell, and had an incontinent episode.The customer also reported that when the patient fell, he hit the freedom driver and damaged the driver's ac power supply and power adaptor.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.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 reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00298, (2) freedom ac power supply s/n (b)(4) (mfr report # 3003761017-2015-00300), and (3) freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2015-00306).The customer reported that while the patient was getting up to get something to eat, the freedom driver stopped working.The customer also reported that the patient lost consciousness, fell, and had an incontinent episode.The customer also reported that when the patient fell, he hit the freedom driver and damaged the driver's ac power supply and power adaptor.The customer also reported that the patient was subsequently switched to the backup freedom driver and the patient felt fine after he was switched.Visual inspection of ac power supply s/n (b)(4) revealed missing rubber feet, a broken strain relief, a cracked housing and a damaged connector.The ac power supply did not meet the acceptance criteria because of the multiple physical anomalies.The ac power supply could not be functionally evaluated because it had a damaged connector.However, the functionality of the power supply was evaluated by other means and the ac power supply was able to operate a freedom driver while connected to a mock tank set to normotensive settings.Despite the customer-reported issue of ac power supply connector damage, risk to the patient was low because a damaged ac power supply would not prevent the freedom driver from performing its life-sustaining functions.Freedom drivers have a redundant power source of onboard batteries.In addition, patients are provided with backup ac power supplies and multiple onboard batteries.The ac power supply 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.
 
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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 (Section G)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5132254
MDR Text Key27992981
Report Number3003761017-2015-00300
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Followup
Report Date 09/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295070-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2014
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 Age58 YR
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