BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 282809 · Received June 15, 2000

    Report

    Report Number
    MW1019158
    Event Type
    Injury
    Date Received
    June 15, 2000
    Date of Event
    August 26, 1999
    Report Date
    June 14, 2000
    Manufacturer
    UNK
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT S/P RT ILEOCOLECTOMY TODAY. AT 2030 PT WAS AWAKE AND RESPONSIVE, APPROXIMATELY 5-10 MINS LATER PT WAS FOUND UNRESPONSIVE. NO RESPIRATIONS NO PULSE. CODE WAS CALLED, CPR WAS INITIATED EPIDURAL TURNED OFF AFTER APPROX 3 MINS OF VENTILATION AND CHEST COMPRESSIONS PT REGAINED A PULSE AND SPONTANEOUS RESPIRATIONS. PT HAD NSR ON MONITOR, O2 SATURATION OF 100% ON NRB, BP 110/60, HR 76. EKG-NL SINUS RHYTHM INITIAL ABG 6.92/CO2 95/O2 152/19/-15.6 97.2%. PT REC'D 0.4MG NARCON X 2. AFTER 2ND NARCON PT MOVED "LUE" SPONTANEOUSLY, 1.AMP BICARB GIVEN, NARCAN 0.4 X 1 GIVEN AND 2ND ABG OBTAINED 7.31/38/163/19/-7.1/98.9% ON NRB. PT TRANSFERRED TO ICU, UPON ARRIVAL PT W/BP 129/54, HR 87, 100% O2 SAT NRB, DILATED PUPILS, PT OPENING EYES TO VOICE, MOVING ALL 4 EXTREMITIES. IN ICU: ADD'L AMP BICARB GIVEN. HEAD CT: NO ACUTE CHANGES, IMP: PT IMPROVING, POSSIBLE NARCOTIC INTOXICATION, PT RESPONDED TO 3 X 0.4MG NARCAN DOSES, NARCOTIC: ANESTHESIA CALLED AND EVALUATED EPIDURAL - POSSIBLE INFILTRATION OF VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INFUSION PUMP FRN UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R| S SYNTHROID, AVAPRO.