BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTA FLOW CENTRIFUGAL PUMP

    MDR report key: 9510802 · Received December 23, 2019

    Report

    Report Number
    3008355164-2019-00018
    Event Type
    Death
    Date Received
    December 23, 2019
    Date of Event
    August 9, 2016
    Report Date
    March 31, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL STATED THE HEART-LUNG MACHINE IS FROM MAQUET. THE QUALITY MANAGER QRC FORWARDED THE LETTER FROM BG RCI TO MAQUET CARDIOPULMONARY DCU ON 2019-12-04. ALL COMPLAINTS IN SAP IN 2016 HAVE BEEN REVIEWED ON 2019-12-06, BUT NO COMPLAINT WAS FOUND THAT COULD BE RELATED TO THE REPORTED EVENT. THEREFORE, COMPLAINT NO (B)(4) WAS CREATED AFTER CONSULTATION WITH DIRECTOR REGULATORY AFFAIRS ON 2019-12-19. IN ORDER TO FULFILL POSSIBLE REPORTING OBLIGATIONS, THIS EVENT WAS REPORTED ON: 2019-12-19 TO ROW; 2019-12-20 EMDR TO USA; 2019-12-20 INITIAL MIR TO GERMANY; 2020-02-13 FOLLOW-UP 1 MIR TO GERMANY. THE INVENTORY (SEE BELOW) OF THE (B)(6) WAS REVIEWED BY QUALITY MANAGER QRC ON 2020-03-04. THE HOSPITAL DOES NOT HAVE ANY HEAR LUNG MACHINE. IN ADDITION TO THAT NO REPAIRS OR INCIDENTS WERE REPORTED IN REGARDS TO THE OTHER MACHINES OWNED BY THE HOSPITAL. THEREFORE MAQUET CARDIOPULMONARY GMBH IS NOT THE LEGAL MANUFACTURER OF THE PRODUCT THE HOSPITAL COMPLAINED. THIS WAS ALSO STATED IN THE LETTER OF (B)(6) & PARTNER (B)(6) ON BEHALF OF MAQUET CARDIOPULMONARY GMBH, TO BG RCI ON 2020-02-13. INVENTORY (B)(6): PRODUCT: RFC 20-970 ROTAFLOW CONSOLE, MATERIAL: 701010874, SERIAL NUMBER: (B)(6), NOTE: MAINTENANCE YES 2020 / COMPLAINTS NO; CARDIOHELP BASE UNIT, 701047999, (B)(6), MAINTENANCE UNTIL 2018 / COMPLAINTS NO; 70104.8012#CARDIOHELP-I, 701048012, (B)(6), MAINTENANCE YES 2020 / COMPLAINTS NO; CARDIOHELP-I, 701048012, (B)(6), MAINTENANCE UNTIL 2018 / COMPLAINTS NO; CARDIOHELP-I, 701048012, (B)(6), MAINTENANCE YES 2020 / COMPLAINTS NO.

    Description of Event or Problem · 0

    INTERNAL REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    LETTER FROM (B)(6) (TRANSLATION): THE PATIENT, WHO WAS INSURED AT THE (B)(6) AGAINST WORK/ROAD ACCIDENTS, WAS ADMITTED TO THE (B)(6) ON (B)(6) 2016 AFTER AN ACCIDENT AT WORK. IN THE CONTEXT OF INTENSIVE MEDICAL TREATMENT, THE USE OF AN EMCO SYSTEM WAS REQUIRED. DURING THE TREATMENT THE EMCO MALFUNCTIONED AND THE INSURED PERSON DIED. THE (B)(6) IS CURRENTLY CHECKING IF DAMAGES CLAIMS ARE ASSERTED AGAINST THIRD PARTIES. IN THE ABOVE CASE, IT CANNOT BE EXCLUDED THAT THE PATIENT DIED AS A RESULT OF INCORRECT TREATMENT OR MALFUNCTION OF THE EMCO SYSTEM. AN EXPERT REPORT IS CURRENTLY BEING PREPARED TO CLARIFY THE CAUSE OF DEATH. ACCORDING TO THE STATEMENT OF THE (B)(6), THE HEART-LUNG MACHINE IS A DEVICE OF YOUR COMPANY. DAMAGE CLAIMS ACC. TO PARAGRAPH 116 SGS X ARE TO BE IN OUR RESPONSIBILITY IN CASE WE HAVE TO PROVIDE ANY PAYMENT ACCORDING TO THE LAW FROM OUR SIDE THEREFORE, AS A PRECAUTION MEASURE AND IN ORDER TO KEEP THE TIMELINE, WE ARE NOTIFYING YOU IN REGARD TO ANY CLAIMS ACCORDING TO PARAGRAPH 116 SGB X. WE KINDLY ASK YOU TO SUBMIT US THE INSURANCE DATA FOR THE PATIENT AS WELL AS THE INSURANCE CERTIFICATE NO. AFTER THAT WE WILL CONTACT THE INSURANCE COMPANY IN ORDER TO DISCUSS THE MEASURES OF A LIMITATION PERIOD. PLEASE CONTACT US IN CASE OF FURTHER CLARIFICATION. THE (B)(6) IS CURRENTLY CHECKING THE CLAIMS FOR DAMAGES DUE TO DEATH OF THE PATIENT. ALSO CHECKING, WHETHER THERE IS A MALFUNCTION OF THE ECMO SYSTEM OR IT WAS A MEDICAL TREATMENT ERROR. THE ABOVE PROCESS IS CHECKING EXACTLY THIS POINT AS FAR AS WE KNOW. IN ORDER TO BE ABLE TO CLAIM DURING THE TIME LIMIT, WE KINDLY ASK YOU (AS IT IS NOT POSSIBLE TO PROVIDE THE CASE DATA CURRENTLY) TO INFORM US AGAINST WHOM THE INVESTIGATION IN REGARD OF THE HOMICIDE OFFENCE SHOULD BE STATED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305009 ROTA FLOW CENTRIFUGAL PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH RF-32 CENTRIFUGAL PUMP COATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death