BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI KIT: 9 F R DISTAL X 4-1/2

    MDR report key: 2945124 · Received January 31, 2013

    Report

    Report Number
    1036844-2013-00040
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K002507
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN PRE-OP. THE SHEATH WAS INSERTED INTO THE PT'S INTERNAL JUGULAR. WHEN FLOATING THE THERMODILUTION CATHETER INTO THE SHEATH, BLOOD BEGAN TO FLOW OUT THE MEMBRANE AS THE CATHETER WAS BEING INSERTED. AS A RESULT, THE SHEATH AS REMOVED AND REPLACED SUCCESSFULLY. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PT DEATH OR COMPLICATIONS REPORTED. ON (B)(4) 2013, FOLLOW UP INFO STATES THEY WERE USING AN EDWARDS 7 FR (B)(4) CATHETER WITH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42295 MULTI-LUMEN/PSI KIT: 9 F R DISTAL X 4-1/2 CRITICAL CARE PSI PRODUCTS FOZ ARROW INTL., INC. RF2084186

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK