BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4241676 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39742
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL CEFAZOLIN AND FORTUM (1G DAILY) FOR PERITONITIS. DIANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723483 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R DIANEAL 1.5% & 2.5%, TITANIUM ADAPTER| TRANSFER SET