BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103081 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32398
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE OCCURRENCE DATE IS UNKNOWN, BUT WAS REFERRED TO AS HAVING OCCURRED A ¿FEW DAYS BACK¿. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS FOR AN UNKNOWN MINICAP, (B)(4) ADDRESSES THE TRANSFER SET, REPORT AND (B)(4) ADDRESSES THE TITANIUM ADAPTER REPORT FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND HAD CLOUDY EFFLUENT, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THE TREATMENT AND THE OUTCOME OF THIS EVENT WERE NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581817 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other TRANSFER SET, TITANIUM ADAPTER| DIANEAL PD2 2.5% SINGLEBAG