BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4142466 · Received October 5, 2014

    Report

    Report Number
    1416980-2014-34565
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHILE HOSPITALIZED FOR AN UNRELATED EVENT, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS. ON AN UNKNOWN DATE, PERITONEAL DIALYSIS WAS DISCONTINUED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED AN INFECTION. IT WAS REPORTED THAT THE PATIENT COLLAPSED AND WAS ADMITTED TO THE HOSPITAL. PER THE DAUGHTER, THE REASON FOR THE COLLAPSE WAS DUE TO A SEVERE INFECTION RELATED TO HER MOTHER¿S DIALYSIS. THE PATIENT WAS PLACED ON UNKNOWN ANTIBIOTICS. THE NATURE OF THE INFECTION WAS NOT REPORTED. THE CAUSE OF THE INFECTION WAS NOT REPORTED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. THE OUTCOME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621961 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.36% AND 2.27%, EXTRANEAL| TRANSFER SET, TITANIUM ADAPTER, CASSETTE