BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA II PUMP

    MDR report key: 635505 · Received September 16, 2005

    Report

    Report Number
    6000001-2005-04027
    Event Type
    Injury
    Date Received
    September 16, 2005
    Date of Event
    August 13, 2005
    Report Date
    August 17, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HOSP'S RISK MANAGER REPORTED A PT WAS RECEIVING DILAUDID ON A PCAII PUMP AND WAS FOUND UNRESPONSIVE. ON THE REPORTED EVENT DATE AT 1200, THE PT'S VITAL SIGN WERE THE FOLLOWING: PULSE 96, RESPIRATIONS 16, OXYGEN SATURATION 97%. AT 1430 THE PT WAS "ASLEEP, NO APPARENT DISTRESS" WAS NOTED. AT 1605 THE PT WAS DISCOVERED UNRESPONSIVE, WITH A PULSE AND RESPIRATIONS OF 0.A CODE WAS CALLED, AND THE MEDICAL STAFF "BAGGED PT "ON 100% OXYGEN. THE PT WAS GIVEN NARCAN 0.8 MG IV AT 1608. AT 1610, 2 MG EPINEPHRINE WAS ADMINISTERED, AND A BAG OF NORMAL SALINE WAS HUNG AT 1612. AN ADDITIONAL DOSE OF EPINEPHRINE, DOSE 1.5MG, WAS ADMINISTERED AT 1614. THE PT HEART RATE AT 1614 WAS 34; AT 1615 THE PT WAS INTUBATED. AT 1616 THE PT'S HEART RATE WAS 64. 1MG OF ATROPINE WAS GIVEN. AT 1619 THE PT WAS DEFIBRILLATED. AT 1620 0.4 MG NARCAN WAS GIVEN. AT 1622 1 MG EPINEPHRINE WAS GIVEN. AT 1630 50 MG OF BICARBONATE AND 1 G CALCIUM CHLORIDE WAS GIVEN. THE PT'S IV SITE WAS LOCATED ON THE RIGHT HAND. THE PCAII PUMP WAS MOUNTED ON AN IV POLE. THE PCAII PUMP WAS FIRST PLACED ON THE PT IN 2005. AT THAT TIME THE PUMP PROGRAMMED FOR PCA DOSE 1 MG EVERY 10 MINUTES WITH A 10 MINUTE LOCKOUT. THE CONCENTRATION OF THE DILAUDID WAS 0.2MG/CC. THE BASAL WAS PROGRAMMED FOR 0.2 MG PER HOUR. THE PUMPS VOLUME WAS ADJUSTED AT 1:07 THE FOLLOWING DAY TO A BASAL OF 0. AN OXYGEN SATURATION MONITOR WAS THE OTHER EQUIPMENT THAT WAS IN THE ROOM. THE SETS USED ON THE PT WAS A 2L3509, BAXTER ANTISIPHON PCA PUMP SET AND 2C7564, BAXTER BURETROL SET. A BURETROL SET WAS CONNECTED TO THE DEXTROSE 5 1/2, WHICH WAS CONNECTED TO THE SET FROM THE PCA, AND RUN TO THE PT. IT WAS KNOWN HOW THE ANTIBIOTICS WERE CONNECTED. THE FACILITIES STANDING ORDER FOR DILAUID, PCA IS "SUGGESTED 0.1-0.5 MG, LOCKOUT INTERVAL DELAY 10-20 MINUTES, BASAL RATE (BACKGROUND INFUSION) 0.5-0.5 MG/HOUR, AND BOLUS DOSE OF 0-2 MG UPON INITIATION OF THERAPY ONLY." THE PRESCRIBED ORDER FOR DILAUDID WAS 1.0 MG. REPORTEDLY PER THE RISK MANAGER, " THE DOSAGE MAY HAVE BEEN PRESCRIBED TOO HIGH." THE PT IS CURRENTLY UNRESPONSIVE AND ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP PCA PUMP MEA BAXTER HEALTHCARE PTE. LTD PCAII NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L| R