BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4091488 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31425
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE EVENT OF PERITONITIS AND ANTIBIOTIC THERAPY WAS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTIONS OF VANCOTROY (2 GRAM, STAT, INTRAPERITONEALLY) AND INJECTIONS OF GENTAMYCIN (20MG, INTRAPERITONEALLY, ONCE DAILY FOR 21 DAYS) FOR PERITONITIS. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE OUTCOME OF THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570771 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

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