BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834201 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05293
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 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 IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. 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 THE POTENTIALLY ASSOCIATED LOT NUMBER H12G20025. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    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 PROVIDED BY A NURSE, IN THE USA. THIS REPORT IS OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PAIN ON THE LEFT SIDE. THE NURSE CLARIFIED THAT THE PAIN ON THE LEFT SIDE WAS A MANIFESTATION OF PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED. DURING THE HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN IP AND CEFEPIME IP (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2012, THE PATIENT WAS RELEASED FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT WAS RE-HOSPITALIZED FOR PERITONITIS, DEHYDRATION, AND ABDOMINAL PAIN THAT HAD CONTINUED FROM THE PREVIOUS HOSPITALIZATION. TREATMENT WITH VANCOMYCIN IP AND CEFEPIME IP (DOSE AND FREQUENCY NOT REPORTED) WAS RESUMED FROM THE PREVIOUS HOSPITALIZATION. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    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 68 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX| HOMECHOICE