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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 False Alarm (1013); Filling Problem (1233); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient.The customer also reported that the freedom driver exhibited fluctuating fill volumes between high 50's to low 40's.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms and fluctuating fill volumes, 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
(b)(4).F/u report 1.
 
Event Description
The customer reported that the freedom driver exhibited intermittent fault alarms while supporting a patient.The customer also reported that the freedom driver exhibited fluctuating fill volumes between high 50's to low 40's.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the exterior of the driver revealed no abnormalities.Visual inspection of the driver's internal components revealed a fractured boss at the bottom left of the front housing and a raised insert at the top right of the front housing.It is unknown how the observed damage occurred, but it did not contribute to the customer-reported issues.The driver met all pre-burn performance and functional testing criteria, which included normotensive and hypertensive settings, with no anomalies or alarms.In addition, the driver was tested for an additional 95 hours and performed as intended with no issues.The customer-reported intermittent fault alarms and fluctuations in fill volumes were not functionally duplicated during incoming failure investigation testing, and the root cause could not be determined.The freedom driver is designed for clinically stable euvolemic patients.If a the circulating volume of a patient goes outside expected ranges, the driver may exhibit alarms indicating that the patient should have additional evaluation with a hospital based driver.The driver performed as intended, and there was no evidence of a device malfunction during investigation testing.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining-functions.The patient was switched to a backup driver with no adverse impact.The driver was serviced which include the replacement of the housings and passed all performance and functional testing before being placed into finished goods.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 (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 Key5226078
MDR Text Key31676721
Report Number3003761017-2015-00384
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 11/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2015
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 Manufacturer11/06/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2015
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 Age48 YR
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