BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2925653 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01668
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS-NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, THERE WAS NO LOT NUMBER GIVEN AND NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE WERE REPORTED. THE COMPLAINT INVESTIGATION DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. THEREFORE THE COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CAUSE IS DETERMINED AS NO DEVICE MALFUNCTION OR USE ERROR 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AN UNRELATED ALARM. THE HOME PATIENT (HP) STATED THAT HE WAS TREATED FOR PERITONITIS. ADDITIONAL INFORMATION WAS PROVIDED BY GLOBAL PHARMACOVIGILANCE (GPV). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH PD4 AND EXTRANEAL THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP), FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPIES WAS UNKNOWN. THE CAUSE OF PERITONITIS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT HAD SEVERE ABDOMINAL PAIN, CHILLS AND FEVER. ON AN UNREPORTED DATE, THE PATIENT WENT TO EMERGENCY AND RECEIVED UNSPECIFIED ANTIBIOTIC WASHES. PATIENT WAS THERE FOR 12-14 HOURS AND DISCHARGED WITH 2 DOSES OF ANTIBIOTICS FOR 2 DAYS, THEN FOLLOWED BY ANOTHER 2 DOSES EACH-ONCE WEEKLY. THE PATIENT WAS STILL ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31246 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention DIANEAL