BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4141331 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34490
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERITONITIS OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2012. 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 CLOUDY EFFLUENT. TREATMENT WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. IT WAS REPORTED THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619956 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL, TRANSFER SET, TITANIUM ADAPTER