BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2143011 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08445
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11C24019 AND H11A25028 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN. THE NURSE BELIEVED THE EVENT WAS UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization DIANEAL PD2 AMBUFLEX THERAPY| HOMECHOICE