BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4161949 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35281
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED IN A FOLLOW UP THAT THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. 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. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH INTRAPERITONEAL INJECTION FORTUM (1 G DAILY, DURATION NOT REPORTED), INTRAPERITONEAL INJECTION VANCOMYCIN (1 GRAM, FREQUENCY AND DURATION NOT REPORTED), AND AMIKACINE (100MG; ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE OUTCOME OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644236 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DIANEAL, TRANSFER SET, TITANIUM ADAPTER