BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103309 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32446
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 17, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AN UNKNOWN ANTIBIOTIC (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT'S CAREGIVER REPORTED THAT THE PATIENT HAD RECOVERED FROM THEIR PERITONITIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584207 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention TRANSFER SET, TITANIUM ADAPTER,| DIANEAL PD4 2.5% AMBUFLEX THERAPY| DIANEAL PD4 1.5% AMBUFLEX THERAPY,