BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDOS HILITE 7000 LT OXYGENATOR

    MDR report key: 10150533 · Received June 12, 2020

    Report

    Report Number
    1713747-2020-00235
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    February 4, 2019
    Report Date
    June 12, 2020
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    DTZ
    PMA / PMN Number
    K133261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OF NOTE, FRESENIUS MEDICAL CARE RENAL THERAPY GROUP, LLC (FMCRTG) HAS ASSUMED RESPONSIBILITY FOR REPORTING ON US DISTRIBUTED MEDOS MEDIZINTECHNIK (B)(4) (MEDOS) PRODUCTS AS PER US FDA REQUIREMENTS. THIS ARRANGEMENT IS REFLECTED IN A QUALITY AGREEMENT BETWEEN FMCRTG AND MEDOS, WHICH WAS MADE EFFECTIVE ON 05/15/ 2020. THE PRODUCT BEING REPORTED WAS CLEARED TO BE MARKETED IN THE US MARKET AS OF 01/09/2014. THE REPORTED EVENT WAS PREVIOUSLY CAPTURED WITHIN MEDOS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OXYGENATOR WAS LEAKING FROM THE BOTTOM OF THE DEVICE. WHILE THERE WAS NO PATIENT INVOLVEMENT REPORTED AT THE TIME OF THE LEAK, IT WAS INDICATED THAT THIS WAS A REUSE OF THE DEVICE. FURTHER INFORMATION WAS NOT PROVIDED. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610669 MEDOS HILITE 7000 LT OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ OGDEN MANUFACTURING PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1