BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 132175 · Received November 13, 1997

    Report

    Report Number
    9610270-1997-00001
    Event Type
    Malfunction
    Date Received
    November 13, 1997
    Date of Event
    September 16, 1997
    Report Date
    October 13, 1997
    Manufacturer
    HOSPAL DASCO SPA
    Product Code
    FII
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: GAMBRO HEALTHCARE HAS MADE A DECISION TO FILE A BASELINE REPORT ON THE PRISMA EVEN THOUGH THE DEVICE REPORTED IN THIS INCIDENT WAS NOT MANUFACTURED IN THE UNITED STATES AND WAS NOT IN DISTRIBUTION IN THE UNITED STATES AT THE TIME THIS REPORT WAS RECEIVED. THIS DECISION IS BASED ON THE FACT THAT GAMBRO HEALTHCARE IS NOW THE MFR OF THE PRISMA WITH DISTRIBUTION IN THE UNITED STATES.

    Description of Event or Problem · 1

    BLOOD NOTED TO BE LEAKING AROUND THE BLOOD PUMP DURING THE TREATMENT DUE TO TUBING WEAR FROM THE BLOOD PUMP ROTOR. BLOOD LOSS WAS NOT SIGNIFICANT; THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRISMA FII HOSPAL DASCO SPA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other