BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4123218 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33481
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(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. THIS IS THE SAME PATIENT CMPLNT-(B)(4), CMPLNT-(B)(4), AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) FORTAZ (DOSE, FREQUENCY, AND DURATION UNKNOWN) AND IP ANCEF (DOSE, FREQUENCY, AND DURATION UNKNOWN) FOR PERITONITIS. DIANEAL THERAPY WAS ONGOING. THE CAUSE OF PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602689 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention TITANIUM ADAPTER, CASSETTE, TRANSFER SET| DIANEAL PD4 2.5% AMBUFLEX, HOMECHOICE,