BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4173706 · Received October 15, 2014

    Report

    Report Number
    1416980-2014-35942
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: THE PERITONITIS OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2014. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH INTRAPERITONEAL UNSPECIFIED ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS REPORTED BY THE PATIENT AS DUE TO ¿THE WATER IN HER TOWN THAT SHE USED TO WASH HER HANDS WITH¿; HOWEVER, THIS COULD NOT BE MEDICALLY CONFIRMED. THE CAUSE OF THIS PERITONITIS EVENT REMAINS UNKNOWN. DIANEAL THERAPIES WERE ONGOING. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655290 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HOME CHOICE,DIANEAL PD4 1.5% AND 2.5% SOLUTIONS| TRANSFER SET, MINICAP AND CASSETTE