BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX M100 SET

    MDR report key: 3935016 · Received July 15, 2014

    Report

    Report Number
    8010182-2014-00031
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 15, 2014
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE COMPLAINT HISTORY FILES AND DEVICE HISTORY RECORD FOR LOT NUMBER 13J1704G SHOWS NO SIMILAR COMPLAINT AND NO NONCONFORMITY WAS RECORDED REGARDING THIS LOT NUMBER. THE PRISMAFLEX M100 SET WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. PICTURES OF THE INVOLVED VENOUS MALE LUER CONNECTOR WERE PROVIDED. IN THE PICTURES, IT APPEARS THERE IS A CRACK AT THE VENOUS MALE LUER CONNECTOR.

    Description of Event or Problem · 1

    LIMITED INFORMATION WAS PROVIDED ABOUT THIS EVENT IN (B)(6) IN WHICH A PATIENT WAS SCHEDULED TO UNDERGO CRRT ON A PRISMAFLEX WITH A PRISMAFLEX M100 FILTER SET. WHILE THE NURSE WAS INFUSING THE CIRCUIT WITH THE PATIENTS' BLOOD, SHE NOTICED THE MALE LUER LOCK CONNECTOR ON THE VENOUS RETURN LINE WAS BROKEN. ASSUMING THE NURSE DID NOT RETURN THE BLOOD IN THE EXTRACORPOREAL CIRCUIT TO THE PATIENT THERE WOULD HAVE BEEN A BLOOD LOSS OF 152ML MAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412199 PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 115306 13J1704G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRISMAFLEX