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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 16-02-80
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402). Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Livanova initiated an investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova deutschland received a report of noise and intermediate stop of a heater-cooler system 3t during priming. No further details are currently available. There was no patient involvement.
 
Manufacturer Narrative
There was no patient involvement. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402). Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Livanova initiated an investigation. 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 of noise and intermediate stop of a heater-cooler system 3t during priming. No further details are currently available. There was no patient involvement.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key13589456
MDR Text Key286084218
Report Number9611109-2022-00079
Device Sequence Number1
Product Code DWC
UDI-Device Identifier04033817901099
UDI-Public(01)04033817901099(11)171206
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-80
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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