BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 332515 · Received May 11, 2001

    Report

    Report Number
    1423500-2001-00773
    Event Type
    Other
    Date Received
    May 11, 2001
    Date of Event
    April 13, 2001
    Report Date
    April 13, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SPOUSE OF HOME PATIENT (HP) REPORTS INCOMPLETE PRIME OF PATIENT LINE OF HOMECHOICE SET. SPOUSE OF HP REPORTS HP WAS ABLE TO REPRIME THE LINE AND COMPLETE TREATMENT. RN REPORTS HP WAS DIAGNOSED WITH PERITONITIS DAY OF INCIDENT. RN REPORTS SHE DOES NOT DIRECTLY ATTRIBUTE DIAGNOSIS TO INCOMPLETE PRIME; HOWEVER, DOES NOT RULE OUT A RELATIONSHIP BETWEEN THE TWO. RN REPORTS HP WAS TREATED WITH 2 GM VANCOMYCIN I.P.X 1 AND 1 GM CEFTAZIDIME I.P. X 1. RN REPORTS HP HAS RESPONDED TO TREATMENT WITH NO RESULTING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22483 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA H01A09040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other