BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR

    MDR report key: 14742261 · Received June 20, 2022

    Report

    Report Number
    8010762-2022-00227
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 19, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    AS MAQUET GMBH IS NOT LEGAL MANUFACTURER OF THE AFFECTED SET THE REPORTING DECISION WAS REEVALUATE TO NON-REPORTABLE. THE LEGAL MANUFACTURER IS HMT. THE COMPLAINT INFORMATION WAS SUBMITTED TO THE LEGAL MANUFACTURER HMT ON 2022-06-28. THE COMPLAINT WILL BE HANDLED BY HMT UNDER #PR (B)(4). HMT AS THE LEGAL MANUFACTURER HAS THE REPORTING RESPONSIBILITY. HMT INFORMED MAQUET GMBH THAT THIS PRODUCT IS NOT DISTRIBUTED IN THE US, THUS THIS REPORT IS NOT REQUIRED. H3 OTHER TEXT : 4113.

    Description of Event or Problem · 0

    THE COMPLAINT WAS RECEIVED FROM GERMANY. IT WAS REPORTED THAT OXYGENATOR PERFORMANCE WAS DEGRADED AND POOR, AND DELTA PRESSURE WAS INCREASED. AFTER THE POOR PERFORMANCE OF THE OXYGENATOR WAS DETERMINED, THE OXYGENATOR WAS CHANGED. AFTER THAT, THE OPERATION WAS CARRIED OUT TO THE END WITHOUT ANY PROBLEMS. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806972 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMO 70000 U #SQUADROX-I ADULT OHNE FILT. 70144135

    Patients

    Seq Age Sex Outcome Treatment
    1 Female