BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4182234 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36301
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THIS EVENT ONE DAY AFTER ONSET. TREATMENT FOR THIS EVENT WAS VANCOMYCIN (INTRAPERITONEALLY, DOSE, FREQUENCY AND DURATION NOT REPORTED) AS WELL AS TWO UNKNOWN ANTIBIOTICS (ORALLY, DOES, FREQUENCY AND DURATION NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SIX DAYS AFTER ADMISSION. PERITONEAL DIALYSIS THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT IS RECOVERING FROM THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662292 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R TRANSFER SET, TITANIUM ADAPTER, 1.5% DIANEAL PD4| CASSETTE, HOMECHOICE, 1.5% DIANEAL PD4