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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 Emits Odor (1425); Overheating of Device (1437); Device Displays Incorrect Message (2591); Temperature Problem (3022); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the patient's freedom driver exhibited an occasional "creaking" sound.The customer also reported that the freedom driver exhibited intermittent fault alarms, was "running hot" and that the onboard batteries felt hot after removing them from the driver.The customer also reported that the patient complained of an occasional burning smell from the air vent on the back of the driver, and that when the burning smell was occurring, it seemed like the driver was working harder and sounded different.The customer also reported that the fill volume (fv) and cardiac output (co) parameters were running lower.The customer also reported that the patient was switched to the backup freedom driver and that after the switch, the fv and co parameters were improved.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because 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.The customer-reported experience could not be reproduced in full.There were no new alarms recorded in the driver's alarm history (only permanent alarms are recorded).During investigation testing, there was no evidence of the driver running hot or causing the onboard batteries to increase in temperature, no perceived smell from the driver, and no significant changes in fill volume or cardiac output over the extended observation run.Despite passing all the functional test criteria, the driver did exhibit a squeaking noise upon operation.This squeaking noise was determined to be caused by the primary motor cam follower hitting the scotch yoke dowel pin in the piston cylinder assembly (pca), which was rubbing against the inside wall of the pca and suggests an increased work overload for the primary motor.This could possibly have caused the overheating and produced a burning smell after prolonged use, although this could not be reproduced or observed during this investigation.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) follow-up report 1.
 
Event Description
The customer reported that the patient's freedom driver exhibited an occasional "creaking" sound.The customer also reported that the freedom driver exhibited intermittent fault alarms, was "running hot" and that the onboard batteries felt hot after removing them from the driver.The customer also reported that the patient complained of an occasional burning smell from the air vent on the back of the driver, and that when the burning smell was occurring, it seemed like the driver was working harder and sounded different.The customer also reported that the fill volume (fv) and cardiac output (co) parameters were running lower.The customer also reported that the patient was switched to the backup freedom driver and that after the switch, the fv and co parameters were improved.There was no reported 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 Key5683709
MDR Text Key46300327
Report Number3003761017-2016-00218
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 05/17/2016
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 Manufacturer05/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2011
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 Age69 YR
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