BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESEP CENTRAL VENOUS OXIMETRY SET

    MDR report key: 2834043 · Received November 15, 2012

    Report

    Report Number
    2015691-2012-18656
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS NOT AVAILABLE FOR RETURN. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. WITHOUT RETURN OF THE CATHETER, A LEAKAGE ON THE SHAFT COULD NOT BE IDENTIFIED. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS, INCLUDING PLACEMENT AND/OR TECHNIQUE, MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PLEURAL EFFUSION (PE) WAS OBSERVED AFTER 2 DAYS OF INJECTING HIGH-CALORIE TRANSFUSION FROM THE PROXIMAL PORT DURING USE. THE CATHETER WAS PROMPTLY REMOVED AFTER THE PROBLEM WAS OBSERVED."THE CATHETER WAS INSERTED 13CM DEEP. THE CUSTOMER CHECKED THE DRAINED EFFLUENT AND FOUND OUT THAT THE BLOOD SUGAR LEVEL WAS AS HIGH AS 550, AND THE CUSTOMER PRESUMED THAT THE TRANSFUSION FLOWED INTO THE PATIENT CHEST. IT IS UNKNOWN HOW MUCH FLUID WAS DRAINED FROM THE PATIENT. THE REMAINDER OF THE PATIENT'S RECOVERY WAS UNEVENTFUL. NO LASTING EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP CENTRAL VENOUS OXIMETRY SET PRESEP CATHETER DQE EDWARDS LIFESCIENCES, PR X3820HSJD

    Patients

    Seq Age Sex Outcome Treatment
    1