BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM PD NXD DISPOSABLE EXTENSION LINE

    MDR report key: 207910 · Received January 26, 1999

    Report

    Report Number
    1423500-1999-00045
    Event Type
    Injury
    Date Received
    January 26, 1999
    Date of Event
    December 24, 1998
    Report Date
    December 28, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT REPORTED QUANTUM EXTENSION LINE SEPARATED FROM ULTRABAG DURING TREATMENT. HOME PATIENT DISCONTINUED TREATMENT AND DID A MANUAL EXCHANGE. THE NEXT DAY, HOME PATIENT PRESENTED WITH ABDOMINAL PAIN AND WAS DIAGNOSED WITH PERITONITIS. HOME PATIENT WAS HOSPITALIZED 2 DAYS AND TREATED WITH ANTIBIOTICS. PER HEALTHCARE PROFESSIONAL HOME PATIENT RESPONTED WELL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM PD NXD DISPOSABLE EXTENSION LINE NXD EXTENSION LINE FKX BAXTER HEALTHCARE CORP. NA H98A28226

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O