BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4182877 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36405
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS USING A PLASTIC ADAPTER AND NOT THE INITIALLY REPORTED BAXTER TITANIUM ADAPTER. ADDITIONALLY, THE PATIENT WAS USING DRAIN LINE/PATIENT LINE EXTENSIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS IS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. TREATMENT FOR THIS EVENT WAS UNKNOWN ANTIBIOTICS (INTRAVENOUSLY, DOSE AND FREQUENCY NOT REPORTED) FOR NINE DAYS BEGINNING THE SAME DAY AS ONSET AND UNKNOWN ANTIBIOTICS (INTRAPERITONEALLY, DAILY, DOSE NOT REPORTED) FOR ELEVEN DAYS BEGINNING NINE DAYS AFTER ONSET. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL EIGHT DAYS AFTER ADMISSION. PERITONEAL DIALYSIS THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661339 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R TITANIUM ADAPTER, AMIA| DRAIN LINE/PATIENT LINE EXTENSION| PLASTIC ADAPTER| DIANEAL, TRANSFER SET, CASSETTE