BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3873061 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18953
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14A26023 AND H14B27060 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. ON THAT SAME DAY, THE PT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. TREATMENT FOR THE EVENT WAS NOT REPORTED. IN THE SAME MONTH AS THE ONSET OF PERITONITIS, THE PT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350106 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization DIANEAL PD4 1.5% AND 2.5% AMBUFLEX| MINICAP TRANSFER SET,| MINICAP,| HOMECHOICE,