BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUART ARTERIAL FILTER,

    MDR report key: 8170420 · Received December 17, 2018

    Report

    Report Number
    8010762-2018-00333
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K001787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 ARTERIAL FILTER QUART HAS BEEN REQUESTED FOR RETURN FOR FURTHER INVESTIGATION AT MAQUET LABORATORY. AS CONFIRMED BY SSU CHINA ON 2018-12-19 THE ARTERIAL FILTER QUART IS NOT AVAILABLE FOR RETURN. SINCE THE DEVICE IS NOT AVAILABLE, FURTHER INVESTIGATION IS NOT POSSIBLE. THE FAILURE COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    (B)(4).

    Description of Event or Problem · 0

    AS STATED BY THE CUSTOMER: "PURGE PORT WAS LEAKING DURING PRIMING." NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010554 QUART ARTERIAL FILTER, FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG HBF 140 70120455

    Patients

    Seq Age Sex Outcome Treatment
    1