BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4222074 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38620
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR AN UNKNOWN MINICAP, (B)(4) ADDRESSES THE AUTOMATED PD SET WITH CASSETTE REPORT, (B)(4) ADDRESSES THE TRANSFER SET REPORT, (B)(4) ADDRESSES THE TITANIUM ADAPTER REPORT AND (B)(4) ADDRESSES THE EXTENSION SET REPORT FOR THIS PATIENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. THE TREATMENT FOR THE PERITONITIS, WHILE THE PATIENT WAS IN THE HOSPITAL, INCLUDED UNSPECIFIED INTRAVENOUS ANTIBIOTICS (DOSES AND FREQUENCIES NOT REPORTED). THE PATIENT CONTINUED RECEIVING ANTIBIOTICS AFTER DISCHARGE FROM THE HOSPITAL, BUT THOSE WERE REPORTED TO BE ADMINISTERED INTRAPERITONEALLY. THE PD THERAPY WAS ONGOING. THE PATIENT RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 4 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702006 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R DIANEAL PD4 1.5% AND 2.5% AMBUFLEX, HOMECHOICE| AUTOMATED PD SET W/CASSETTE| TRANSFER SET, TITANIUM ADAPTER, EXTENSION SET