BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 341158 · Received July 3, 2001

    Report

    Report Number
    1423500-2001-01029
    Event Type
    Malfunction
    Date Received
    July 3, 2001
    Date of Event
    May 1, 2001
    Report Date
    May 8, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER CANADA REPORTS "AIR IN PT LINE" DUE TO INCOMPLETE PRIME OF PT LINE OF HOMECHOICE SET. AFFILIATE REPORTS PT WAS INFUSED WITH EXCESS AIR AS NOTED BY SHOULDER PAIN. AFFILIATE REPORTS NO X-RAY WAS GIVEN TO PT TO CONFIRM PRESENCE OF AIR. NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF INCIDENT PER AFFILIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30181 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN