BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4250269 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40517
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER MINICAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND PERITONEAL CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH ANCEF (2 GRAM, DAILY, IP) FOR PERITONITIS. ON AN UNKNOWN DATE IN THE SAME MONTH, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737524 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R EXTRANEAL, DIANEAL 2.5%, HOMECHOICE| TRANSFER SET, TITANIUM ADAPTER, CASSETTE