BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4123557 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33513
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PERITONITIS WAS DIAGNOSED ON AN UNKNOWN DATE THE ¿WEEK PRIOR TO (B)(6) 2014¿. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, NAUSEA AND VOMITING. THE SAME DAY AS HOSPITALIZATION THE PATIENT BEGAN TREATMENT WITH INTRAPERITONEAL (IP) VANCOMYCIN 2 GRAMS, TWO TIMES A WEEK FOR 4 WEEKS (ONGOING) AND IP FORTAZ 4 GRAMS, TWO TIMES A WEEK FOR 4 WEEKS (ONGOING). THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE DUE TO THE PATIENT MISSING A STEP AND NOT PAYING ATTENTION; HOWEVER, THIS COULD NOT BE CLINICALLY CONFIRMED BY THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). IT WAS REPORTED DIANEAL THERAPIES WERE ONGOING. THE PATIENT WAS DISCHARGED ONE DAY AFTER ADMISSION. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600012 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE, DIANEAL PD4 1.5%, 2.5% AMBUFLEX| TRANSFER SET, TITANIUM ADAPTER, CASSETTE