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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited changes in pressure waveforms while the patient was sitting in a chair.The customer also reported that the right side cardiac output (co) declined and no alarms were reported during the reported event.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.After the driver switch, the ventricular assist device (vad) coordinator called the syncardia clinical support specialist to report the readings returned to normal.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited pressure waveform changes, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the companion 2 driver exhibited changes in pressure waveforms while the patient was sitting in a chair.The customer also reported that the right side cardiac output (co) declined and no alarms were reported during the reported event.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.After the driver switch, the ventricular assist device (vad) coordinator called the syncardia clinical support specialist to report that the readings returned to normal.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no anomalies.During investigation testing, a diastolic waveform delay was observed, confirming the reported issue.The driver was disassembled, and when the left pilot valve cable was manually manipulated, the left side pressure and flow waveform timing shifted.The left and right pilot valves were inspected, and there were significant amounts of contamination inside both pilot valves.The origin of the contamination was unknown.Although contamination is known to affect pilot valve performance, it was unlikely that the contamination was the cause of the irregular waveform timing since it was reproduced via manipulation of the left pilot valve cable.The root cause of the reported irregular waveform timing was a malfunction of the left pilot valve assembly.The left and right pilot valve assemblies were replaced, and the companion 2 driver passed all final performance testing.This failure mode posed a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.Syncardia will continue to monitor and trend this issue 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 COMPANION 2 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 Key5534570
MDR Text Key41778372
Report Number3003761017-2016-00109
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 03/16/2016
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 Other Health Care Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2016
Initial Date FDA Received03/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2015
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 Age60 YR
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