BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2893553 · Received January 2, 2013

    Report

    Report Number
    1416980-2013-00094
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 11, 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). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12H10115 AND H12H18068. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 2 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF REINFECTION FROM AN INFECTION, PERITONITIS, AND WEAK IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED A REINFECTION FROM AN INFECTION. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS REINFECTION FROM AN INFECTION. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS STILL WEAK AND CONTINUED TO TAKE ANTIBIOTICS. THE PATIENT WAS RECOVERING FROM THIS EPISODE OF PERITONITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| R DIANEAL PD2 AMBUFLEX