BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2864110 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06839
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 2 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. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12B10050, H12C27078, H12F26065 AND H12F21058 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    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 IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. TREATMENT WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE OUTCOME OF THIS PERITONITIS EVENT IS UNKNOWN. PER THE NURSE, THE PERITONITIS EVENT WAS UNRELATED TO BAXTER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other DIANEAL PD2 AMBUFLEX