BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2926262 · Received January 16, 2013

    Report

    Report Number
    2016493-2013-00055
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES WERE RETURNED FOR INVESTIGATION. LOG REVIEW ONLY. THE RESULTED LOG REVIEW FOR A POSSIBLE OVER INFUSION OF THE DRUG DILAUDID (HYDROMORPHONE) HAS BEEN COMPLETED. THE USER INITIALLY PROGRAMMED THE PCA AS REPORTED FOR A DOSE OF 0.1MG WITH A LOCKOUT OF 6 MINUTES. IT APPEARS, BASED ON THE REPORTED INTENDED DOSING OF 0.1MG, THAT THE USER LATER MADE AN ERROR DURING THE REPROGRAMMING OF THE PCA INFUSION. THE REPROGRAMMING OCCURRED AS A RESULT OF A SYSTEM ERROR. THE USER REPROGRAMMED THE PCA INFUSION TO INFUSE A DOSE OF 1MG WHICH WAS TEN TIMES GREATER THAN THE REPORTED INTENDED DOSING OF 0.1MG. TWO PCA DELIVERIES WITHIN AN APPROXIMATE 9 MINUTE TIME PERIOD WERE PERFORMED THAT DELIVERED 10ML TO THE PT. PRIOR TO THE REPROGRAMMING EVENT THE PCA DELIVERED 5 ML TO THE PT WITHIN A TIME PERIOD OF 1.267 HOURS. NO ADDITIONAL PCA INFUSIONS WERE PERFORMED AFTER THE NOTED 10ML DELIVERY. THE ROOT CAUSE FOR THE OVER INFUSION OF THE DRUG DILAUDID IS ATTRIBUTED TO USER PROGRAMMING.

    Description of Event or Problem · 1

    BIOMED REPORTED A POST-OP PT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE NURSING UNIT WITH DILAUDID PCA AND WAS LATER FOUND UNRESPONSIVE; THEY ARE UNSURE BUT QUESTION WHETHER THE PT MAY HAVE RECEIVED AN OVER INFUSION. HYDROMORPHONE 0.2 MG/ML IN 25 ML VOLUME WAS TO INFUSE VIA PCA ONLY (NO BASAL OR BOLUS) AT 0.1 MG WITH LOCKOUT OF EITHER 6 MINUTES OR 15 MINUTES. RISK MANAGER IS NOT SURE WHY THERE WERE 2 DIFFERENT LOCKOUT PERIODS REPORTED. PT HAD RESPIRATORY DEPRESSION AND NARCAN REVERSAL WAS GIVEN WITH GOOD RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25091 ALARIS PCA MODULE FRN CAREFUSION CORP 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ALARIS PCA MODULE SET MODEL/LOT UNK| ALARIS PC UNIT, S/N (B)(4)| ALARIS PUMP MODULE, SN (B)(4)