BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMOD 70000 QUADROX-ID

    MDR report key: 8217643 · Received January 4, 2019

    Report

    Report Number
    8010762-2019-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 8, 2018
    Report Date
    May 29, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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). INVESTIGATION IN PROGRESS. 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)(6). THE DEFECTIVE OXYGENATOR HAS BEEN INVESTIGATED IN THE LAB: THE OPTICAL EXAMINATION OF THE OXYGENATOR DID NOT REVEAL ANY DETECTABLE DEFECTS. NO CLOTS WERE NOTICED DURING RINSING AND CLEANING. THE LEAK TEST ACCORDING TO LV 201 AND THE TEST RUN (PRIMING) WERE ALSO WITHOUT ANY ISSUES.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: THEY HAD TO CHANGE OUT QUADROX ON PATIENT BECAUSE THE OXYGENATOR WAS NOT WORKING. HE DESCRIBED IT WAS NOT A CLOTTING ISSUE BUT CLAIMED THAT THE QUADROX WAS NOT OXYGENATING. ADDITIONAL INFORMATION: THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. (B)(4).

    Description of Event or Problem · 0

    REF.: # (B)(4). CUSTOMER REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9653 HMOD 70000 QUADROX-ID OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HMOD 70000 70123579

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention