BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3130481 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13402
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS H12K04030 AND H13A26016. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231106 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization DIANEAL 2.5% SINGLEBAG| HOMECHOICE, DIANEAL 1.5% ULTRABG