BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PCA MODULE

    MDR report key: 2101508 · Received May 18, 2011

    Report

    Report Number
    2016493-2011-00340
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICES WERE SENT TO BIOMED TO CHECK FOR ANY MECHANICAL PROBLEMS. THE LOGS WERE REQUESTED ON THREE SEPARATE OCCASIONS, HOWEVER, WE HAVE NOT RECEIVED THEM AS OF THIS DATE. IF THE LOGS ARE RECEIVED, A F/U REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SUSPECTED OVER DOSE OF MORPHINE. A (B)(6) YEAR OLD FEMALE ADMITTED FOR THE REMOVAL OF 10 CM MALIGNANT PELVIC MASS ORDERED MORPHINE POST OP AT 21:05 ON (B)(6) 2011. IT STARTED AT 2 MG DEMAND DOSE AND 8 MIN LOCKOUT, WITH 2 MG LOADING DOSE. NO BOLUS DOSE OR CONTINUOUS INFUSION ORDERED. THE VITAL SIGNS WERE WITHIN NORMAL LIMITS AT 00:00 ON (B)(6) 2011. AT 0230 THE PT SOUNDED "WEIRD" AND COULD NOT BE UNDERSTOOD. WHEN THE NURSE ARRIVED IN THE ROOM AT (B)(6), THE PT WAS UNRESPONSIVE AND NOT BREATHING. AFTER 0.04 NALOXONE WAS ADMINISTERED, THE PT IMMEDIATELY BECAME ALERT. TWO SUBSEQUENT 0.04 DOSES OF NALOXONE WERE REQUIRED TO REMAIN ALERT. THE PT WAS PUT ON NALOXONE DRIP AND TRANSFERRED TO ICU. PT WAS ON NALOXONE DRIP FOR 1 HOUR, REMAINED IN ICU FOR 5 HOURS FOR OBSERVATION. MORPHINE 5MG/ML WAS THE CONCENTRATION AND A 30ML SYRINGE WAS USED. A TOTAL OF 2.3 ML WAS USED TO PRIME, 0.4 ML ADMINISTERED FOR LOADING DOSE, APPROX 10.3 ML SELF ADMINISTRATION FROM 2105 UNTIL THE NURSE WAS CALLED. THE PT STATED SHE THOUGHT SHE WAS SUPPOSED TO DEMAND A DOSE EVERY 8 MINS REGARDLESS OF WHETHER SHE NEEDED IT, SHE REMEMBERED FORCING HERSELF A DEMAND DOSE EVEN THOUGH SHE WAS NO LONGER IN PAIN. THE CUSTOMER INDICATED THAT SHE "WAS 99% SURE THE EVENT HAD NOTHING TO DO WITH THE PUMP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PCA MODULE MEA CAREFUSION CORP. 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other ALARIS PC UNIT: SERIAL # UNK| (DATE OF TX: (B)(6) 2011, (B)(6) 2011)