BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-STAT CELITE ACT CARTRIDGE

    MDR report key: 1938986 · Received December 28, 2010

    Report

    Report Number
    1938986
    Event Type
    Death
    Date Received
    December 28, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    JBP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD AN INTERVENTIONAL RADIOLOGY PROCEDURE FOR PERIPHERAL ARTERIAL DISEASE ON (B)(6)2010; ACTS WERE MONITORED AND WHEN THE ACT WAS LESS THAN 180, THE ARTERIAL SHEATH WAS PULLED; AT THIS TIME, THE PT BECAME HYPOTENSIVE; WAS TOO UNSTABLE FOR CT SCAN; TAKEN TO ICU; NOTED TO HAVE ABDOMINAL DISTENTION. PT BECAME BRADYCARDIC, THEN ASYSTOLIC; CPR PERFORMED AND REGAINED BP; TAKEN TO OPERATING ROOM - BEFORE SURGERY COULD BE DONE. PT CODED AND EXPIRED. NOTED THAT PT WAS BLEEDING FROM ARTERY ORIFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CELITE ACT CARTRIDGE INVITRO DIAGNOSTIC TESTING JBP ABBOTT POINT OF CARE, INC. 510308

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death FENTANYL 200 MG| ISO OSMOLAR VISIPAQUE 320 130 ML| HEPARIN 9500 IU FOR ACT 250-300| DILAUDID 0.5 MG| VERSED 5 MG