BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4182537 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36374
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS THERAPY. ALTHOUGH THE CAUSE OF THE PERITONITIS WAS UNKNOWN, IT WAS NOTED THAT THE PATIENT HAD BEEN PERFORMING THERAPY IN A POTENTIALLY COMPROMISED ENVIRONMENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH GENTAMYCIN INTRAVENOUSLY (DOSE, FREQUENCY, AND DURATION NOT REPORTED). UPON DISCHARGE FROM THE HOSPITAL, THE PATIENT BEGAN TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC INTRAPERITONEALLY (DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660128 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R HOMECHOICE, DIANEAL PD4 AMBUFLEX| CASSETTE, TRANSFER SET, , FLEXICAP