BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4120727 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33307
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 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: (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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. THE REPORTED CAUSE OF DEATH WAS A HEART ATTACK. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT PRIOR TO PASSING AWAY. THERAPY WAS ONGOING UNTIL THE TIME OF DEATH; HOWEVER, IT WAS NOT REPORTED IF THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF DEATH. IF ADDITIONAL RELEVANT INFORMATION BECOMES 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 CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT DID NOT REQUIRE HOSPITALIZATION FOR THE EVENT. THE PATIENT WAS TREATED WITH INJECTION MEROPENEM INTRAPERITONEALLY (IP) (1G, ONCE DAILY) AND INJECTION VANCOMYCIN IP (1G, ONCE EVERY 5TH DAY) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, ANTIBIOTIC TREATMENT WAS ONGOING. IT WAS UNKNOWN IF THE PATIENT WAS RECOVERING FROM THE EVENT. DIANEAL THERAPY WAS REPORTED TO BE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601331 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| R TRANSFER SET, TITANIUM ADAPTER, DIANEAL ULTRABAG