BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2832224 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05115
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H12F22056 AND H12D12086. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM THE NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED. PD THERAPY WAS ONGOING. PD RN STATED THAT "POSSIBLY RELATED TO COMPLIANCE ISSUES" IT IS UNKNOWN IF THE EVENT WAS RELATED TO THE HOME CHOICE MACHINE, DISPOSABLE PARTS,OR DIANEAL THERAPY. THE PD RN STATED THAT SHE "HAS ONLY BEEN AT THE CLINIC FOR 2 MONTHS AND DOESN'T KNOW VERY MUCH ABOUT THE PATIENT YET." NO FURTHER INFORMATION WAS PROVIDED.

    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 30 YR Hospitalization DIANEAL PD4 AMBUFLEX