BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4092551 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31462
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 27, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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 MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS REPORTED THAT THE PERITONITIS WAS DUE TO TOUCH CONTAMINATION; HOWEVER, THIS WAS NOT MEDICALLY CONFIRMED AND THE EXACT CAUSE REMAINS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND RELEASED THE NEXT DAY. THE PATIENT WAS TREATED WITH THE TOBRAMYCIN (INTRAPERITONEALLY IN THE EXTRANEAL TWIN BAG, FREQUENCY, DOSE, AND DURATION NOT REPORTED) AND CIPROFLOXACIN (1 TABLET TWICE DAILY, ORALLY, DOSE AND DURATION NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572552 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R TITANIUM ADAPTER, TRANSFER SET| DIANEAL 1.5%, DIANEAL 2.5%, EXTRANEAL