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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
Model Number 595000-001
Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm and a drop in beat rate, 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.(b)(4).
 
Event Description
The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the beat rate of the driver dropped from 142 beats per minute to 120 beats per minute during the fault alarm.The patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.
 
Manufacturer Narrative
Visual inspection of the driver found metallic debris on the exhaust fan, exhaust fan cover, piston cylinder assembly (pca), motor-gearboxes and speaker printed circuit board assembly (pcba), and the secondary motor cam follower out of bottom dead center position (bdc).It was also observed that the primary motor dragged, wobbled, and made a loud grinding noise.Despite passing all functional test criteria, the driver exhibited a loud grinding noise upon operation.This grinding noise was likely caused by the primary motor cam follower hitting the scotch yoke dowel pin in the pca, rubbing against the inside wall of the pca resulting in the observed metallic debris.The customer-reported fault alarm and change in beat rate were confirmed and reproduced during investigation testing as they were the expected result of the engagement of the secondary motor as evidenced by the secondary motor cam follower being out of bdc position.The reason for the secondary motor engagement could not be determined conclusively, however, if the secondary motor cam follower moves sufficiently out of bdc such that it allows engagement with the scotch yoke, back-emf (electromagnetic field) from motion of the secondary motor will trigger the driver to disable the primary motor and engage the secondary motor.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
 
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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
MDR Report Key7439840
MDR Text Key105916727
Report Number3003761017-2018-00119
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/22/2018
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 Model Number595000-001
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/03/2018
Initial Date FDA Received04/18/2018
Supplement Dates Manufacturer Received04/03/2018
Supplement Dates FDA Received08/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age42 YR
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