BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103224 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32402
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). 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 SAME PATIENT AS CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION (INJ.) OF AMIKACIN 50 MG (FREQUENCY NOT REPORTED), INJ. OF REFLIN 500 MG (FREQUENCY NOT REPORTED) AND INJ. OF HEPARIN 1000 IU (FREQUENCY NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE OUTCOME OF THIS PERITONITIS EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582522 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention TRANSFER SET AND TITANIUM ADAPTER| DIANEAL PD2 2.5% SOLUTION