BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4203615 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37598
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 11, 2014
    Report Date
    September 30, 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 ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION WITH THE CUSTOMER, IT WAS DETERMINED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO THE PATIENT¿S NON-BAXTER PERITONEAL DIALYSIS (PD) CATHETER WAS EMBODIED IN THEIR PERITONEUM INCORRECTLY. THEREFORE, THE BAXTER TRANSFER SET IS NO LONGER A SUSPECT PRODUCT IN THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS TREATED WITH CEFTAZIDIME STARTING 2 DAYS AFTER THE REPORTED EVENT (1.5MG, INTRAPERITONEALLY, DAILY FOR 21 DAYS) FOR PERITONITIS. DIANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, TREATMENT WITH ANTIBIOTICS WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682296 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DIANEAL 1.5%, 2.5% AND 4.25% SINGLEBAG| DIANEAL 1.5% AND 2.5% ULTRABAG,| MINICAP, TITANIUM ADAPTER,| CASSETTE AND FLEXICAP