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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 Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2015
Event Type  malfunction  
Event Description
The customer reported that the patient was in the hospital for infection, stable on the freedom driver.The customer also reported that the driver beat rate drifted to 135 beats per minute (bpm) from the set beat rate of 132 bpm.The patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a beat rate drift, 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) follow-up report 1.
 
Event Description
The customer reported that the patient was in the hospital for infection, stable on the freedom driver.The customer also reported that the driver beat rate drifted to 135 beats per minute (bpm) from the set beat rate of 132 bpm.The patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no abnormalities.The driver in "as received" condition passed all test requirements, which included normotensive and hypertensive settings, with no anomalies or alarms.During investigation testing, the customer-reported drift in beat rate issue was duplicated by connecting and disconnecting external ac (alternating current) power.This issue was previously investigated, which determined the root cause to be a malfunction of the motor controller printed circuit board assembly (pcba).A motor controller pcba that previously met performance test acceptance criteria was installed into the driver.The driver was powered on and tested in the same method as stated above.The driver performed as intended with no drift in the beat rate.This failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The driver was serviced, which included the replacement of the motor controller pcba, 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 Contact
carole marcot
1992 e. silverlake road
ce 2596
tucson, AZ 85713
5205451234
MDR Report Key4488074
MDR Text Key5567541
Report Number3003761017-2015-00044
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,Followup
Report Date 01/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2015
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 Manufacturer01/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
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 Age64 YR
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