BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLS#D-QUADROX-I ADU.O.FILTE

    MDR report key: 8101551 · Received November 26, 2018

    Report

    Report Number
    8010762-2018-00305
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 8, 2018
    Report Date
    February 11, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002.

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON- (B)(4). THE DEFECTIVE PART HAS BEEN SCRAPPED BY THE CUSTOMER, THEREFORE NO INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: BLOOD LEAKING DURING ECMO THERAPY. ADDITIONAL INFORMATION: THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. (B)(4).

    Description of Event or Problem · 0

    REF.: #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940515 PLS#D-QUADROX-I ADU.O.FILTE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG 70116406

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention