BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2830164 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04957
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 26, 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 PATIENT COINCIDENT WITH COINCIDENT WITH DIANEAL PD4 1.5% AND 2.5% THERAPIES. DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER (B)(4) TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS MANIFESTED AS ABDOMINAL PAIN, CLOUDY EFFLUENT AND FEVER. THE CAUSE OF PERITONITIS WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH ALFACEF (2GRAM PER DAY, ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT IS RECOVERING. THE EVENT OF PERITONITIS IS 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 62 YR Hospitalization| R DIANEAL PD4 2.5%| DIANEAL PD4 1.5%