BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2942367 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02869
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12I10105 AND H12G28028 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AMBUFLEX AND ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46681 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization DIANEAL AMBUFLEX AND DIANEAL PD4 ULTRABAG| HOMECHOICE