BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2864738 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06880
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT FOR PERITONITIS -NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE LOT NUMBER WAS UNKNOWN. 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL PD4 1.5% AND DIANEAL 2.5% PD4 THERAPIES. DURING A CALL WITH BAXTER (B)(4) TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED VOMITING AND BLOOD PRESSURE DECREASE. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT RENDERED FOR THE EVENTS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT DIED DUE TO EPILEPSY, RESPIRATION FAILURE, BLOOD PRESSURE DECREASE AND DEBILITATION (ONSET DATES NOT REPORTED). THE CAUSE OF DEATH WAS EPILEPSY, RESPIRATORY FAILURE, DECREASED BLOOD PRESSURE AND DEBILITATION. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS. THE PERITONITIS WAS UNRELATED TO BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 2.5%| DIANEAL PD4 1.5%