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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-80
Device Problems Device Displays Incorrect Message (2591); Electronic Property Issue (2928)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2016
Event Type  Malfunction  
Manufacturer Narrative

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: k052601). Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the sorin heater-cooler system 3t displayed an error code on the patient side during in-service and burn smell was detected coming from the machine. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate and found that the machine had been removed from service by the customer. The service representative confirmed the burn smell, however was unable to identify any damage or burning on the internal cables, boards and components. Further testing found that the stirrer motor on the patient bridge was not working, as the movement of the motor was restricted. A replacement patient bridge was ordered and sorin group deutschland has requested that the replaced be returned for investigation upon completion of the replacement. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.

 
Event Description

Sorin group (b)(4) received a report that the sorin heater-cooler system 3t displayed an error code on the patient side during in-service and burn smell was detected coming from the machine. There was no patient involvement.

 
Manufacturer Narrative

The livanova representative went on-side an replaced the patient bridge to resolve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to service. The patient bridge was returned for further investigation. As root cause dirty pumps could be identified.

 
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Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key5992292
MDR Text Key56098023
Report Number9611109-2016-00692
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-80
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2015
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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