BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4250218 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40279
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PAST MEDICAL HISTORY OF HYPERTENSION IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PATIENT WAS NOT DIAGNOSED WITH OR HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR UNRELATED MEDICAL CONDITIONS. SINCE THE PATIENT WAS NOT DIAGNOSED WITH OR HOSPITALIZED FOR PERITONITIS, AN UNKNOWN BAXTER MINICAP IS NO LONGER A SUSPECTED PRODUCT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE EVENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWENTY NINE DAYS AFTER HOSPITALIZATION AND WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736846 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R TRANSFER SET, CASSETTE, HOMECHOICE,| DIANEAL 1.5%, 2.5% & 4.25% AMBUFLEX,