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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Filling Problem (1233); Short Fill (1575); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that when the patient was switched to this freedom driver at the set beat rate of 133, the driver displayed a beat rate of 129 and the patient's displayed fill volumes dropped from 40-50s to 20-30s.The customer also reported that the patient was switched to a companion 2 driver to monitor him for approximately one hour, and then he was switched to another freedom driver.There was no reported adverse patient impact.This alleged 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 will be returned to syncardia for investigation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that when the patient was switched to this freedom driver at the set beat rate of 133, the driver displayed a beat rate of 129 and the patient's displayed fill volumes dropped from 40-50s to 20-30s.The customer also reported that the patient was switched to a companion 2 driver to monitor him for approximately one hour, and then he was switched to another freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no abnormalities.Review of the alarm history (eeprom) did not reveal any new alarms that were recorded while the driver was supporting the patient, and the customer did not report any alarms.The driver was tested and passed all test requirements, which included nominal normotensive and hypertensive patient simulator settings, with no anomalies or unintended alarms.The driver was then tested for an additional 48 hours, and there was no variation in beat rate or decrease in fill volume.The investigation determined that the freedom driver performed as intended, and there was no evidence of a device malfunction.It is possible that the variation in beat rate and drop in fill volume were the result of the patient's condition at the time of the customer experience.The freedom driver was serviced and passed all final performance testing.The reported issue posed a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.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 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
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 Key5683728
MDR Text Key47231203
Report Number3003761017-2016-00220
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 05/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
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 Manufacturer06/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2014
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 Age45 YR
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