BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4221977 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38603
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT BEGAN TREATMENT WITH VARIOUS DOSES OF VANCOMYCIN INTRAPERITONEALLY (IP, FREQUENCY NOT REPORTED) FOR PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. FOUR DAYS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. TEN DAYS LATER, THE PATIENT WAS RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700876 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R HOMECHOICE AND DIANEAL| TITANIUM ADAPTER, MINICAP, CASSETTE