BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050#PLS SET

    MDR report key: 8064424 · Received November 13, 2018

    Report

    Report Number
    8010762-2018-00302
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 30, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (B)(4). RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6). PART IS NOT AVAILABLE FOR INVESTIGATION, THEREFORE NO LAB INVESTIGATION CAN BE PERFORMED. MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. THUS THE FAILURE COULD NOT BE CONFIRMED. THIS COMPLAINT WILL BE CLOSED DUE TO NO PART AVAILABLE AND COMPLAINT WILL BE REOPENED WHEN SIGNIFICANT INFORMATION WILL BE AVAILABLE. 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

    THE AFFECTED PRODUCT WAS REQUESTED FOR MANUFACTURER LABORATORY INVESTIGATION BUT WAS NOT YET RECEIVED. (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

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

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: TRANSLATION FROM GERMAN INTO ENGLISH: AFTER 2 DAYS LEAKAGE AT ROTAFLOW CENTRIFUGAL PUMP. THE SET WAS REPLACED. NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902642 BE-PLS 2050#PLS SET CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG BE-PLS 2050#PLS SET 70125601

    Patients

    Seq Age Sex Outcome Treatment
    1