BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4250956 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40558
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 21, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Product Problem
    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 TITANIUM ADAPTER. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A CONNECTION ISSUE. THE CAREGIVER CLAMPED THE PD CATHETER AND BROUGHT THE PATIENT INTO THE PD CLINIC IMMEDIATELY. PER THE PDRN THERE WAS NO CONFIRMED BREAK IN ASEPTIC TECHNIQUE AFTER THE DISCONNECTION OCCURRED. THE PATIENT SUBSEQUENTLY ACQUIRED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, FEVER AND ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED FOR 9 DAYS. ON THE SAME DAY AS THE ONSET OF PERITONITIS, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN, INTRAPERITONEALLY (IP, DOSE AND FREQUENCY UNKNOWN) FOR TWO WEEKS FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH CEFEPIME (IP, FOR TWO WEEKS, DOSE AND FREQUENCY UNKNOWN) FOR PERITONITIS. TWENTY DAYS AFTER THE ONSET, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS. PD THERAPY WAS ONGOING. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736770 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R TRANSFER SET, HOMECHOICE, DIANEAL PD2 AMBUFLEX