BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4102856 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32344
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER MINICAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING FOLLOW UP, IT WAS DETERMINED THAT THE CAUSE OF THE PERITONITIS WAS A USE ERROR. THE HOME PATIENT REMOVED THE PULL RING CAP ON A PHYSIONEAL BAG PRIOR TO BEING CONNECTED AND FAILED TO FOLLOW PROPER THERAPY STEPS. THE MINICAP TRANSFER SET IS NO LONGER A SUSPECTED PRODUCT FOR 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 MANIFESTED BY ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT BEGAN TREATMENT WITH CEFTAZIDIME (ONCE A DAY, DOSE NOT REPORTED) IP AS TREATMENT TO PERITONITIS. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS. EXTRANEAL AND PHYSIONEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584777 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R EXTRANEAL, PHYSIONEAL 1.5%| TRANSFER SET, TITANIUM ADAPTER,