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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 Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that the freedom driver exhibited a "filter alarm" (fault alarm) while supporting a patient at home.The customer also reported that the patient changed the filter but the alarm persisted.The customer also reported that the patient switched to the backup freedom driver.The customer also reported that there was no adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, 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.Review of the driver's alarm history revealed a single new documented alarm (alarm code 36), which was likely one of the alarms experienced by the customer.This was the only alarm logged by the driver (temporary/recoverable alarms are not logged).Alarm code 36 can be produced during power cycling of the freedom driver, during onboard battery exchange while operating only on battery power, or if an onboard battery is not fully latched in place.The driver passed all incoming and functional test requirements with no anomalies or alarms.Additionally, an extended observation run and a battery insertion/extraction test, was performed and the driver functioned as intended with no evidence of a device malfunction.The customer reported alarms couldn't be reproduced during investigation testing; therefore, a root cause for the reported issue was not 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 a "filter alarm" (fault alarm) while supporting a patient at home.The customer also reported that the patient changed the filter but the alarm persisted.The customer also reported that the patient switched to the backup freedom driver.The customer also reported that there was no adverse patient impact.
 
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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 Key5642639
MDR Text Key46170308
Report Number3003761017-2016-00193
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 Initial,Followup
Report Date 04/30/2016
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 Lay User/Patient
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/30/2016
Initial Date FDA Received05/09/2016
Supplement Dates Manufacturer Received07/31/2017
Supplement Dates FDA Received08/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2015
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 Age23 YR
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