BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2820014 · Received November 5, 2012

    Report

    Report Number
    1416980-2012-04111
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12G27152, H12G17039 AND H12F12073 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 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 IN THE USA OF PERITONITIS, ELEVATED BLOOD GLUCOSE OF 330-440 AND ILLNESS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT HAD PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT HAD AN ELEVATED BLOOD GLUCOSE OF 330-440. THE NURSE STATED THAT ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS OF ELEVATED BLOOD GLUCOSE AS WELL AS THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFEPIME. IT WAS ASSUMED THAT THE CAUSE OF THE PERITONITIS MIGHT BE DUE TO THE PETS IN THE HOUSE BUT IT WAS UNKNOWN. THE PATIENT HAD NOT YET BEEN RETRAINED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE AT HOME, THE PATIENT WAS VERY SICK. TREATMENT NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT RECOVERED FROM BEING SICK. ON AN UNREPORTED DATE THE PATIENT RECOVERED FROM THE ELEVATED BLOOD GLUCOSE OF 330-440. PER THE NURSE, THE EVENTS WERE 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 51 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX