BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAS II - ALBA

    MDR report key: 438062 · Received January 12, 2003

    Report

    Report Number
    MW1027229
    Event Type
    Malfunction
    Date Received
    January 12, 2003
    Date of Event
    January 12, 2003
    Report Date
    January 12, 2003
    Manufacturer
    HEALTH PRODUCTS (DIV OF ALBA-WALDENSIAN INC.)
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD IV FLUIDS ORDERED AS WELL AS "VENODYNES." PT WAS SOMEWHAT CONFUSED AT THE TIME. PT DECIDED TO GO TO THE BATHROOM AND ATTEMPTED TO ATTACH THE DISCONNECTED AIR LINE FROM THE PAS II TO AN ACCESS PORT ON THEIR IV LINE. THE PAS II USES LUER ADAPTER TO CONNECT THE DEVICE TO THE CALF SLEEVES. THE MACHINE WAS OFF AND PT CROSS THREADED THE LUER ADAPTER. NO AIR ENTERED THE LINE, BUT IT COULD HAVE BEEN A DISASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS II - ALBA PULSATURE ANTI-EMBOLISM SYSTEM JOW HEALTH PRODUCTS (DIV OF ALBA-WALDENSIAN INC.) PAS II *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other