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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 Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problems Vertigo (2134); No Consequences Or Impact To Patient (2199)
Event Date 11/15/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00395) and (2) freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00396).The customer reported that the freedom driver s/n (b)(4) exhibited a beat rate of 122 beats per minute (bpm) though the beat rate was set at 125 bpm.Additionally, the fill volume (fv) exhibited on the driver was at 49 milliliters (ml).The customer also reported that the patient was taken to the hospital with reports of feeling a head rush.The customer also reported that the patient was subsequently switched to the backup freedom driver s/n (b)(4) at the hospital, where the driver exhibited a fault alarm.The customer also reported that the patient was subsequently switched to another freedom driver and the patient felt fine after he was switched.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
Corrected to patient/lay user.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed split housings at the bottom left side of the driver.Visual inspection of the driver's internal components revealed a broken tip on the u21 pressure sensor on the main printed circuit board assembly (pcba).Review of the electronic data revealed a fault code which is consistent with a broken u21 pressure sensor.The broken u21 pressure sensor was determined to be the root cause of the customer-reported fault alarm.Based upon the damage observed during the visual inspection including the split housings, the most likely root cause of the broken u21 pressure sensor is rough handling or an impact shock.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).
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) primary freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00395) and (2) freedom driver s/n (b)(4) (mfr report # 3003761017-2015-00396).The customer reported that the freedom driver s/n (b)(4) exhibited a beat rate of 122 beats per minute (bpm) though the beat rate was set at 125 bpm.Additionally, the fill volume (fv) exhibited on the driver was at 49 milliliters (ml).The customer also reported that the patient was taken to the hospital with reports of feeling a head rush.The customer also reported that the patient was subsequently switched to the backup freedom driver s/n (b)(4) at the hospital, where the driver exhibited a fault alarm.The customer also reported that the patient was subsequently switched to another freedom driver and the patient felt fine after he was switched.
 
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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
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5242751
MDR Text Key32204660
Report Number3003761017-2015-00396
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 11/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2012
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 Age62 YR
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