BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103511 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32478
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS SAME PATIENT AS IN CMPLNT-(B)(4), CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION (INJ.) VANCOMYCIN (125 MG (MILLIGRAMS), FREQUENCY AND ROUTE NOT REPORTED) AND INJ. AMIKACIN (50 MG, ONCE A DAY AND ROUTE NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE ACTION TAKEN WITH PD THERAPY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584458 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DIANEAL 2.5% ULTRABAG, MINICAP TRANSFER SET| TITANIUM ADAPTER