BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID ADULT O.FILT

    MDR report key: 12725422 · Received October 30, 2021

    Report

    Report Number
    8010762-2021-00578
    Event Type
    Malfunction
    Date Received
    October 30, 2021
    Report Date
    February 17, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE OXYGENATION PERFORMANCE OF A QUADROX-ID WAS LOW DURING TREATMENT. THE QUADROX-ID WAS DISCARDED BY THE CUSTOMER, THUS NO TECHNICAL INVESTIGATION COULD BE PERFORMED. HOWEVER FOLLOWING PROBABLE ROOT CAUSES WERE ALREADY IDENTIFIED IN THE RISK ASSESSMENT QUADROX-ID ADULT: - SPECIFICATION OF REQUIREMENTS FOR EXTRACORPOREAL BLOOD-GAS EXCHANGERS (OXYGENATORS) INTENDED FOR SUPPLY OF OXYGEN AND REMOVAL OF CARBON DIOXIDE NOT MET - INSUFFICIENT FLUSHING - LEAKS OR DAMAGE TO THE OXYGENATOR. FURTHER IT WAS STATED THAT THE PATIENT WAS INFECTED WITH COVID-19. AS STATED BY THE GETINGE MEDICAL AFFAIRS TEAM AND IN REFERENCE TO AVAILABLE LITERATURE COVID-19 DISEASES CAN BE ASSOCIATED WITH INTRAVASCULAR COAGULATION ACTIVATION, MICROCIRCULATION DISORDERS AND INCREASED RISK OF THROMBOEMBOLISM DESPITE GOOD SYSTEMIC ANTICOAGULATION. THE INCREASED RISK OF THROMBOSIS AND COAGULOPATHY IN ECMO PATIENTS MAY BE THE RESULT OF A COMBINATION OF PROCESSES DRIVEN BY COVID-19 OCCURRING IN SYNERGY WITH THE KNOWN EFFECT(S) OF THE EXTRACORPOREAL CIRCUIT ON THE COAGULATION SYSTEM. CLOT FORMATION IN AN EXTRACORPOREAL CIRCUIT CAN LEAD TO A REDUCTION AND/OR BLOCKAGE, AND THUS, AN REDUCTION OF THE DIFFUSION PATH LOWERING THE GAS TRANSFER PERFORMANCE. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "LOW PERFORMANCE" COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING. REFERENCE: [1] YUSUFF H, ZOCHIOS V, BRODIE D. "THROMBOSIS AND COAGULOPATHY IN COVID-19 PATIENTS REQUIRING EXTRACORPOREAL MEMBRANE OXYGENATION" ASAIO J. 2020;66(8):844-846. DOI:10.1097/MAT.0000000000001208.

    Description of Event or Problem · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER PATIENT AND PERFUSION DATA WAS REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE OXYGENATION OF THE QUADROX-ID WAS INSUFFICIENT. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623308 QUADROX-ID ADULT O.FILT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMOD 70000-USA #SQUADROX-ID ADULT O.FILT 3000168944

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown