BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4203091 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37560
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 BACTERIAL INFECTION. THE BACTERIAL INFECTION WAS MANIFESTED BY CLOUDY EFFLUENT ALONG WITH SYMPTOMS OF CHILLS, ABDOMINAL PAIN AND FEVER. THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE BACTERIAL INFECTION WAS NOT REPORTED. TREATMENT AND OUTCOME WERE NOT REPORTED. FOUR DAYS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681355 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization TITANIUM ADAPTER, TRANSFER SET, EXTRANEAL| DIANEAL PD4 1.5 AND 2.5% AMBUFLEX AND ULTRABAG