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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and traced it back to a faulty patient bridge.Replacing the defective component fixed the issue.Subsequent testing found no further issue and the device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.
 
Event Description
Livanova (b)(4) received a report that the heater-cooler system 3t displayed an error message when the patient pump was turned on during setup.There was no patient involvement.
 
Manufacturer Narrative
The bridge was returned to livanova (b)(4) for further investigation.Inspection of the returned device revealed that one of the pump units was very dirty and had bearing damage.A broken electronics motor was identified on the other pump.These damaged components were determined to be the cause of the reported issue.It is unknown how the components became damaged.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUSCHLAND
lindberghstr. 25
munich 80939
GM  80939
MDR Report Key7167320
MDR Text Key96627433
Report Number9611109-2018-00016
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/24/2018
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 Health Professional
Device Model Number16-02-85
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2017
Initial Date FDA Received01/05/2018
Supplement Dates Manufacturer Received06/26/2018
Supplement Dates FDA Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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