BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4222187 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38626
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (PREVIOUSLY REPORTED AS PATIENT DEATH; THIS EVENT IS A SERIOUS INJURY ONLY.) THE EXACT DATE OF THE EVENT WAS NOT PROVIDED; IT WAS REPORTED THAT THE PERITONITIS EVENT OCCURRED AT ¿THE END OF (B)(6) 2014¿. UPDATED INFORMATION: THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT, VOMITING, PAIN, AND DIFFICULTY BREATHING. THE PATIENT WAS INTERMITTENTLY HOSPITALIZED FOR PERITONITIS FOR APPROXIMATELY ONE MONTH WITH ADMISSION DURATION OF FOUR DAYS, THEN SEVEN DAYS, AND THEN TEN DAYS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DURATION SEVEN DAYS, DOSE, FREQUENCY, AND ROUTE UNKNOWN) FOR PERITONITIS. PERITONEAL DIALYSIS THERAPY WAS DISCONTINUED AND THE PATIENT WAS PLACED ON HEMODIALYSIS THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. 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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH UNKNOWN ANTIBIOTICS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE ACTION TAKEN WITH DIANEAL THERAPIES WAS NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERED FROM PERITONITIS PRIOR TO DEATH. IT WAS NOT REPORTED IF DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702802 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H| R DIANEAL 1.5%, 2.5%,TITANIUM ADAPTER, TRANSFER SET| DIANEAL 1.5% THERAPY, DIANEAL 2.5% THERAPY