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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Fatigue (1849); Tachycardia (2095); Discomfort (2330); Low Cardiac Output (2501)
Event Date 08/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient at home.The patient then went to the hospital.The customer also reported that the patient's fill volume dropped to the 30s and cardiac output decreased to 2.7 during the alarms.The alarms lasted less than 10 seconds.The customer also reported that during the alarms, the patient felt a "sinking" sensation and was short of breath throughout the day.The customer also reported that the patient's blood pressure was stable, and that there were no weight changes or clinical signs of fluid volume overload.The beat rate was increased from 130 to 134 bpm in an attempt to fix the problem.The customer also reported that there were no more fault alarms at the new beat rate however the fill volume continued to drop to the 30s.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact and the parameters improved.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The driver in "as received" condition passed all test requirements with no anomalies or alarms.The driver was tested for an additional 90 hours and was determined to function as intended with no evidence of a device malfunction.The customer-reported alarms and fill volume and cardiac output fluctuations could not be reproduced during investigation testing, therefore a root cause for the reported issues not be conclusively determined.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.(b)(4).
 
Event Description
The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient at home.The patient then went to the hospital.The customer also reported that the patient's fill volume dropped to the 30s and cardiac output decreased to 2.7 during the alarms.The alarms lasted less than 10 seconds.The customer also reported that during the alarms, the patient felt a "sinking" sensation and was short of breath throughout the day.The customer also reported that the patient's blood pressure was stable, and that there were no weight changes or clinical signs of fluid volume overload.The beat rate was increased from 130 to 134 bpm in an attempt to fix the problem.The customer also reported that there were no more fault alarms at the new beat rate however the fill volume continued to drop to the 30s.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact and the parameters improved.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5928802
MDR Text Key54582635
Report Number3003761017-2016-00306
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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 Initial,Followup
Report Date 08/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2012
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 Age57 YR
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