BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER COOLER UNIT

    MDR report key: 9681212 · Received February 7, 2020

    Report

    Report Number
    8010762-2020-00054
    Event Type
    Death
    Date Received
    February 7, 2020
    Report Date
    April 30, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANAGING DIRECTOR OF MAQUET CARDIOPULMONARY FORWARDED THE LETTER FROM A RELATIVE OF THE PATIENT TO MAQUET CARDIOPULMONARY GMBH, DCU ON 2020-01-20. ALL COMPLAINTS SINCE 2014 WERE REVIEWED ON 2020-01-21, BUT NO COMPLAINT WAS FOUND THAT COULD BE RELATED TO THE REPORTED EVENT. THEREFORE COMPLAINT NO (B)(4) WAS CREATED AFTER CONSULTATION WITH THE DIRECTOR OF REGULATORY AFFAIRS ON 2020-01-23. IN ORDER TO FULFIL POSSIBLE REPORTING OBLIGATIONS, THIS EVENT WAS REPORTED ON: 2020-01-28 INITIAL MIR TO UNITED KINGDOM , 2020-02-11 INITIAL EMDR , 2020- 02-12 INITIAL REPORT TO ROW , 2020-03-27 FOLLOW UP 1 MIR TO UNITED KINGDOM. ON 2020-02-26 MCP SENT A LETTER TO THE RELATIVES OF THE PATIENT TO INFORM THEM ABOUT THE ONGOING COMPLAINT INVESTIGATION. A REQUEST FOR CLARIFICATION OF THE COMPLAINT REPORT WAS SENT TO THE CUSTOMER ON 2020-03-10 (REFERENCE NO FOI REQUEST (B)(4)). THE FREEDOM OF INFORMATION (FOI) DEPARTMENT FROM THE SOUTH TEES HOSPITAL NHS FOUNDATION TRUST HAS RESPONDED TO THE FOI REQUEST (B)(4) ON 2020-04-27. DURING THE INVESTIGATION IT WAS CONFIRMED THAT THE HOSPITAL DOES NOT USE ANY MAQUET CARDIOPULMONARY (MCP) DEVICES. THEREFORE MAQUET CARDIOPULMONARY GMBH IS NOT THE LEGAL MANUFACTURER OF THE PRODUCT IN QUESTION AND THIS IS NOT A CUSTOMER PRODUCT COMPLAINT BY DEFINITION (REFERENCE TO (B)(4) CUSTOMER PRODUCT COMPLAINT HANDLING PROCESS).

    Description of Event or Problem · 0

    COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    VERY LIMITED INFORMATION IS CURRENTLY AVAILABLE AS SOLE SOURCE OF DATA IS VAGUE LETTER RECEIVED FROM FAMILY MEMBER OF DESCENDENT. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BASED ON THE CLAIMED EVENT REPORTED BY THE PATIENTS FAMILY WE BECAME AWARE ON 2020-01-20 AND OPEN UP THAT COMPLAINT. THE PATIENTS FAMILY REPORTED THEY BELIEVE THEIR FATHER CONTRACTED A BACTERIAL INFECTION WITH A SOURCE OF A MAQUET PRODUCT IN CONNECTION WITH A SURGERY IN 2014 AND SUBSEQUENT DEATH IN 2017. IT IS UNCLEAR WHETHER THE INFORMATIONS IN THE REPORT FROM DECEDENT¿S FAMILY ARE OF FACTUAL NATURE. THUS IT IS NOT CLEAR IF THE PRODUCT IN QUESTION WAS THE ULTIMATE CAUSE OF DEATH OR ITS INITIAL SOURCE. COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143992 HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY GMBH 701034371 - HCU 30

    Patients

    Seq Age Sex Outcome Treatment
    1 Death