BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3102208 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11775
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO SWITCHED OUT SOLUTION BAGS DURING THERAPY AND WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS USER ERROR. THE HP WAS TREATED WITH VANCOMYCIN (1 G, IP, EVERY DAY) AND CEFTAZIDIME (1 G, IP, EVERY DAY). ON (B)(6) 2013, TREATMENT WITH VANCOMYCIN WAS WITHDRAWN. ON (B)(6) 2013, TREATMENT WITH CEFTAZIDIME WAS WITHDRAWN.. THE HP WAS REPORTED TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204564 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention