BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-TYPE BLOOD SET

    MDR report key: 286873 · Received July 19, 2000

    Report

    Report Number
    6000001-2000-00395
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    June 1, 2000
    Report Date
    June 30, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS TWO INCIDENTS IN ONE DAY IN WHICH LEAKAGE OCCURRED AT THE BASE OF THE HAND PUMP. ONE SET HAD SMALL AMOUNT OF LEAKAGE AND THE OTHER SET HAD A LARGER AMOUNT. RPTR DID NOT KNOW IF PRESSURE WAS BEING APPLIED. ALSO, RPTR STATED RPTR DID NOT KNOW IF BLOOD ENTERED ORIFICES. HOWEVER, NO PT OR "HCP" COMPROMISE WAS REPORTED. NO PROBLEMS SINCE THE TWO INCIDENTS. SAMPLES DISCARDED DUE TO BEING CONTAMINATED WITH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE BLOOD SET BLOOD SET KSB BAXTER HEALTHCARE CORP. NA GR133983

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN