BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4093360 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31512
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS EVENT WAS REPORTED TO BE DUE TO THE HP USING A DRIED OUT MINICAP. THE HP WAS NOT HOSPITALIZED FOR THE PERITONITIS. THE HP WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN (2 GRAMS, ONE TIME), IP CEFTAZIDIME (1 GRAM, ONCE), AND IP CEFAZOLIN (1 GRAM, ONCE) FOR THE EVENT. IT WAS REPORTED THAT SIXTEEN DAYS LATER, CEFTAZIDIME AND CEFAZOLIN WERE DISCONTINUED. THE HP HAS RECOVERED FROM THE EVENT. ON AN UNREPORTED DATE, THE HP WAS RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571243 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention DIANEAL ULTRABAG PD4 THERAPY