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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 Device Alarm System (1012); Short Fill (1575); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2014
Event Type  malfunction  
Event Description
The customer reported that the freedom driver exhibited fluctuating low fill volumes while supporting a patient.The customer also reported that while the patient was preparing to leave the house and go to the emergency room, the freedom driver exhibited an irreversible fault alarm.The patient was subsequently switched to the backup freedom driver.When the patient arrived at the hospital, he was transferred to the 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 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 supplemental mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the freedom driver exhibited fluctuating low fill volumes while supporting a patient.The customer also reported that while the patient was preparing to leave the house and go to the emergency room, the freedom driver exhibited an irreversible fault alarm.The patient was subsequently switched to the backup freedom driver.When the patient arrived at the hospital, he was transferred to the companion 2 driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the interior of the driver revealed that the potentiometer used to adjust the primary motor beat rate was a non-specified component.The presence of this component in this driver is not related to this complaint.The non-specified potentiometer is functionally equivalent to the specified potentiometer.The potentiometer was replaced with a specified potentiometer.The driver then passed all final performance testing.Syncardia has initiated a corrective action (capa) to address the non-specified potentiometer issue.The capa is in process.Review of the alarm history (eeprom) data confirmed that the driver did not record a permanent fault alarm while supporting the patient and the customer-reported fault alarm and fill volume fluctuations were not able to be duplicated during functional testing.The driver passed all test requirements with no anomalies or alarms.The investigation concluded that the driver functioned as intended, and there was no evidence of a device malfunction.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform 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 Key4380583
MDR Text Key16089256
Report Number3003761017-2014-00323
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 Facility,health professional,use
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 12/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2012
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 Age36 YR
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