BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX M100 SET

    MDR report key: 4160062 · Received October 10, 2014

    Report

    Report Number
    8010182-2014-00046
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 8, 2014
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLEX M100 SET WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE LEAKING FROM THE PICTURES PROVIDED. NO DAMAGE COULD BE SEEN IN THE PICTURES. THERE WAS NO LEAKAGE REPORTED DURING THE PRIMING OF THE PRODUCT BEFORE THE EVENT. IT COULD BE SEEN THAT THE Y-CONNECTOR WAS ALSO ATTACHED WHICH IS CONSIDERED "OFF LABEL" USE. THE REVIEW OF THE COMPLAINT HISTORY FILES AND DEVICE HISTORY RECORD FOR THE LOT WHICH INCLUDED THE AFFECTED M100 SET, LOT NUMBER 14A2303G, SHOW NO NONCONFORMITIES.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING CRRT ON A PRISMAFLEX MACHINE WITH A PRISMAFLEX M100 SET. DURING TREATMENT, BLOOD WAS OBSERVED LEAKING FROM THE ARTERIAL LUER LOCK. THE TREATMENT WAS STOPPED AND THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT RESULTING IN AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 167 ML. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE BLOOD LOSS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638805 PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 115306 14A2303G

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other PRISMAFLEX (SN : UNKNOWN)