BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4090749 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31390
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF ONSET IS UNKNOWN, BUT WAS REPORTED TO BE SOMETIME LAST YEAR. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS FOR AN UNKNOWN MINICAP, (B)(4) ADDRESSES THE TRANSFER SET REPORT AND (B)(4) ADDRESSES THE TITANIUM ADAPTER REPORT FOR THIS PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. THE TREATMENT WAS NOT REPORTED. THE PATIENT BELIEVED THAT THE INFECTION WAS DUE TO A KINK IN THEIR CATHETER. THE CATHETER WAS REMOVED AND THE PATIENT WAS TEMPORARILY PLACED ON HEMODIALYSIS THERAPY. THE PATIENT HAS SINCE, RETURNED TO PD THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569862 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL 1.5%| TITANIUM ADAPTER,TRANSFER SET, EXTRANEAL