BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2231860 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11597
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11F06076, H11E08025 AND H11D16047 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA.

    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 REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF DIARRHEA, PERITONITIS WITH (B)(6) AND (B)(6) AND BLOOD INFECTION IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED DIARRHEA. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS AND DIARRHEA. TREATMENT WAS NOT REPORTED AND AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THE EVENTS WERE NOT RELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX