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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Unexpected Shutdown (4019)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(4).Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t was giving an unknown error code and did not operate properly.Reportedly the system would shut down.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: the reported issue turned out to be about error code associated to cardioplegia pump malfunction which is not likely to contribute to serious injury.Thus, the reported event has been re-assessed as non reportable.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich
MDR Report Key10010014
MDR Text Key195894171
Report Number9611109-2020-00287
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K191402
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 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
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
Date Manufacturer Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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