BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 316913 · Received February 16, 2001

    Report

    Report Number
    1423500-2001-00133
    Event Type
    Malfunction
    Date Received
    February 16, 2001
    Date of Event
    January 1, 2001
    Report Date
    January 18, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTS INCOMPLETE PRIME OF PATIENT LINE OF HOMECHOICE SET. RN REPORTS HOME PATIENT (HP) HAS NO INITIAL DRAIN AND WAS SUBSEQUENTLY INFUSED WITH AIR. PER RN, HP REPORTED SHOULDER PAIN DUE TO THIS EXCESS AIR INFUSED INTO PERITONEUM. RN INSTRUCTED HP TO DO A MANUAL EXCHANGE TO ALLEVIATE DISCOMFORT. NO X-RAY OR PAIN MEDICATIONS WERE GIVEN TO HP. RN REPORTS PAIN HAS SUBSIDED ON OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6560 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA H00J23101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN