BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 8865443 · Received August 6, 2019

    Report

    Report Number
    8010182-2019-00162
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 13, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEYZIEU
    Product Code
    KDI
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALTERNATE PHONE NUMBER: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX SET, THE PRE BLOOD PUMP (PBP) WAS LEAKING. THIS WAS NOTICED AFTER TWO ALARMS WERE TRIGGERED (MALFUNCTION SCALES PBP AND A FLOW PROBLEM PBP). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659090 NI DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MEYZIEU NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISMAFLEX MACHINE