BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2863005 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06674
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 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. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE 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. 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. 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). FURTHER INFORMATION WAS RECEIVED FROM A NURSE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE TREATMENT FOR PERITONITIS WAS STOPPED. THE REPORTED FEVER WAS CONSIDERED TO BE A MANIFESTATION OF THE PERITONITIS. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT ON (B)(6) 2012. PER THE NURSE, THIS PERITONITIS EVENT WAS UNRELATED TO BAXTER PRODUCTS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FEVER AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER (B)(4) TECHNICAL SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED FEVER. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. ON THE SAME DAY, THE PATIENT STARTED TREATMENT WITH ALFACEF (2GM, DAILY) AND MEDFURIM (2GM, DAILY) (ROUTES NOT REPORTED) FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    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 55 YR Hospitalization| R DIANEAL PD4 2.5%