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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Insufficient Heating (1287)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2018
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 review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
 
Event Description
Livanova (b)(4) received a report that a heater-cooler system 3t was not heating during setup.There was no patient involvement.
 
Event Description
See initial.
 
Manufacturer Narrative
The information that the reported issue was affecting the cardioplegia side was received.The event has been re-evaluated as non reportable since a heater-cooler system 3t not heating on the cardioplegia circuit is not likely to result in death or serious injury.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key7888288
MDR Text Key120699648
Report Number9611109-2018-01231
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 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
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 Received08/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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