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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 397002-001
Device Problems Kinked (1339); Device Operates Differently Than Expected (2913); Output below Specifications (3004)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited sudden drop in cardiac output.The customer also reported that the problem may have come from the patient; the patient's pulmonary graft was discovered kinked during transplant surgery later the same day.
 
Event Description
The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited sudden drop in cardiac output.The customer also reported that the problem may have come from the patient; the patient's pulmonary graft was discovered kinked during transplant surgery later the same day.
 
Manufacturer Narrative
The companion 2 driver was returned to syncardia for evaluation.The electronic patient data were reviewed and confirmed the customer-reported issue.During investigation testing, the sudden drop in flow was not able to be reproduced; however, the customer reported that the patient's pulmonary graft was discovered to be kinked, which could have contributed to the reported drop in cardiac output.Investigation testing did reveal a delay in flow waveform timing which can lead to decreased flow.The root cause was determined to be a malfunction of the right pilot valve.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
MDR Report Key6772144
MDR Text Key82154453
Report Number3003761017-2017-00137
Device Sequence Number1
Product Code LOZ
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
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2017
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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