BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4221062 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38542
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. FIVE DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE NEXT DAY, THE PATIENT BEGAN TREATMENT WITH GENTAMYCIN, INTRAPERITONEALLY (IP, FOR 14 DAYS, DOSE NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 2 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702843 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R DIANEAL PD4 2.5% & 4.25% AMBUFLEX, TRANSFER SET,| EXTENSION SET, CASSETTE, FLEXICAP, HOMECHOICE