BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX M100 SET

    MDR report key: 3922371 · Received July 9, 2014

    Report

    Report Number
    8010182-2014-00030
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 7, 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. PICTURES OF THE INVOLVED PRODUCT WERE PROVIDED. IN THE PICTURES, IT APPEARS THE VENOUS LINE WHICH CONNECTS TO THE DIALYZER IS DAMAGED. NEVERTHELESS, WE CANNOT IDENTIFY A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT WITH THE PROVIDED PICTURES. THE REVIEW OF THE COMPLAINT HISTORY FILES AND DEVICE HISTORY RECORD FOR LOT NUMBER 13J2505G SHOWS NO OTHER COMPLAINT AND NO NONCONFORMITY WAS RECORDED REGARDING THIS LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING CRRT WITH A PRISMAFLEX M100 FILTER SET. AT THE BEGINNING OF TREATMENT, THE NURSE OBSERVED AN EXTERNAL LEAK ON THE VENOUS LINE WHERE IT CONNECTS TO THE FILTER. TREATMENT WAS STOPPED AND REPORTEDLY, THERE WAS NO BLOOD LOSS OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400390 PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 115306 13J2505G

    Patients

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