BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3131712 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13595
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 23, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS OF POTENTIALLY ASSOCIATED LOT NUMBERS H13A13014 AND H13C04076, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THESE LOTS. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT. THE PATIENT HAD EXPERIENCED A BLOOD INFECTION AND CLOUDY PERITONEAL DIALYSIS EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENTS. ON THE SAME DAY, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS INTRAVENOUSLY (DOSE AND FREQUENCY NOT REPORTED) FOR THE BLOOD INFECTION. HOWEVER, THE TREATMENT FOR CLOUDY PD EFFLUENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237554 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention TRANSFER SET AND MINICAP| DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG