BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LUMEN/PSI SET

    MDR report key: 1696652 · Received May 21, 2010

    Report

    Report Number
    1036844-2010-00147
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    March 1, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K011761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARROW MULTI-LUMEN ACCESS CATHETER (MAC) CATHETER WAS USED AS AN INTRODUCER WITH AN EDWARDS SWAN GANZ PULMONARY ARTERY CATHETER INSERTED THROUGH THE MAC. PT WAS AN (B) (6) FEMALE. THE ANAESTHETIST AT THE HOSPITAL THAT WAS PRESENT AT THE TIME OF THE EVENT SAID, THE PT HAD A SUDDEN RISE IN BLOOD PRESSURE, THEN A RAPID FALL IN PRESSURE. THE PT DIED AND THERE WAS NO POST MORTEM CARRIED OUT AND THE LOCATION OF THE DEVICE IS UNK. THE SPRING WIRE GUIDE (SWG) WAS USED FOR PLACEMENT. IT IS UNK HOW LONG THE DEVICE HAD BEEN IN USE. A VERBAL REPORT WAS RECEIVED FROM THE DIRECTOR OF PERIOPERATIVE SERVICES AT THE HOSPITAL; HE WAS NOT PRESENT AT THE TIME OF THE INCIDENT. THIS STATEMENT WAS MADE BY THE CLINICIAN: "A SOLUTION OF NORADRENALINE WAS RUNNING THROUGH ONE OF THE SIDE ARMS OF THE PULMONARY CATHETER. THE CATHETER WAS PARTIALLY WITHDRAWN THROUGH THE MAC INTRODUCER SHEATH. A BOLUS OF FLUID WAS GIVEN THROUGH THE SIDE PORT OF THE MAC CATHETER. THE PT'S BLOOD PRESSURE INCREASED AND THE END RESULT WAS ALLEGEDLY A RUPTURED AORTA AND DEATH." IT WAS PRESUMED THAT THE SIDE LUMEN OF THE PA WAS INSIDE THE MAC AND NORADRENALINE HAD ACCUMULATED INSIDE THE CENTRAL LUMEN OF THE MC AND WAS BOLUSED WHEN THE FLUIDS WERE GIVEN VIA THE MAC SIDEPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN/PSI SET MULTI-LUMEN ACCESS CATHETERS DYB ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NORADRENALINE| EDWARDS SWAN GANZ PULMONARY ARTERY CATHETER