BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 2133362 · Received June 15, 2011

    Report

    Report Number
    1036844-2011-00174
    Event Type
    Death
    Date Received
    June 15, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REFERENCE MDR #1036844-2011-00173 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THEY WERE ATTEMPTING TO PLACE THE CATHETER IN THE PT'S FEMORAL WHO WAS SEPTIC. A SECOND KIT WAS OPENED AND DURING INSERTION, THEY WERE THREADING THE SPRING WIRE GUIDE (SWG) AND IT BECAME KINKED. AS A RESULT, EVERYTHING WAS REMOVED AND A THIRD ATTEMPT WAS MADE. THERE WAS A DELAY IN TREATMENT. ADD'L INFO REC'D ON (B)(6) 2011 FROM THE SALES REP STATED, A THIRD ATTEMPT WAS MADE USING A COOK SWG AND WAS SUCCESSFUL. THERE WAS APPROX A 1 HR DELAY IN TREATMENT. THE PT LATER EXPIRED. THE PHYSICIAN INDICATED, THE PT'S CAUSE OF DEATH WAS SEPTIC AND THEY DO NOT KNOW IF THIS CONTRIBUTED TO THE PT EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC RF0115609

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death COOK SPRING WIRE GUIDE