BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4130788 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33955
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING FOLLOW UP THAT, ON (B)(6) 2014, THE PATIENT WAS TREATED WITH FORTAX (1300 MILLIGRAM EVERY DAY FOR FOURTEEN DAYS, INTRAPERITONEALLY) FOR PERITONITIS. ON (B)(6) 2014, THE PATIENT WAS TREATED WITH VANCOMYCIN (1000 MILLIGRAM EVERY FIVE DAYS) FOR THE EVENT. ON (B)(6) 2014, TREATMENT WITH VANCOMYCIN WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE PERITONITIS ON (B)(6) 2014. (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS NOT REPORTED. IN THE SAME MONTH, THE PATIENT WAS HOSPITALIZED FOR THE EVENT FOR ONE NIGHT. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE OF ADMINISTRATION NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607624 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% SINGLEBAG| CASSETTE AND HOMECHOICE| TRANSFER SET AND TITANIUM ADAPTER