BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4200997 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37375
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. THIS REPORT REFERENCES THE (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. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE DURING THE SAME MONTH AS HOSPITAL ADMISSION, THE PATIENT WAS DISCHARGED. ON AN UNKNOWN DATE, PD CATHETER WAS REMOVED AND THE PATIENT WAS PLACED ON IN CENTER HEMODIALYSIS (HD). AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT AND REMAINED ON HD THERAPY WITH PLANS TO SWITCH BACK TO PD THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683998 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

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