BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4140659 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34402
    Event Type
    Death
    Date Received
    October 3, 2014
    Date of Event
    June 27, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT REFERENCES THE SAME PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE SAME DAY AS ONSET THE PATIENT WAS TREATED WITH ¿RAPID PD EXCHANGES¿ AND ONE DOSE OF INTRAPERITONEAL (IP) VANCOMYCIN, 1500MG. THE SAME DAY THE PATIENT BEGAN TREATMENT WITH IP GENTAMICIN 60MG (ONE TIME), THEN 40 MG DAILY FOR 18 DAYS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. FOUR DAYS AFTER COMPLETION OF THE ANTIBIOTIC THERAPY, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS A STROKE. IT WAS REPORTED THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT WHEN HE PASSED AWAY. IT WAS REPORTED THE PATIENT WAS NOT PERFORMING PD THERAPY AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619758 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R DIANEAL PD4 1.5% AND 2.5% SOLUTIONS| TRANSFER SET, TITANIUM ADAPTER, CASSETTE