BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3901289 · Received June 18, 2014

    Report

    Report Number
    2016493-2014-00285
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER'S REPORT OF A POSSIBLE OVERINFUSION WAS NOT CONFIRMED. A REVIEW OF THE ASSOCIATED PCU EVENT LOG FOR THE PCA INFUSION INDICATES THAT THE DEVICE WAS PROGRAMMED AS REPORTED BY THE CUSTOMER. A MORPHINE STANDARD (2 MG/ML) PCA INFUSION WAS STARTED AT 2:34 PM ON (B)(6) 2014. THE INFUSION WAS PROGRAMMED AS A PCA ONLY INFUSION (NO BASAL) WITH PRESET PARAMETERS OF 1.4 MG BOLUS, LOCK OUT EVERY 6 MINUTES AND MAX LIMIT OF 12 MG/HR. THE INFUSION RAN UNTIL 11:09 PM THAT EVENING WITH 27 BOLUSES BEING DELIVERED FOR A TOTAL OF 37.8 MG. NO DEVICES WERE RETURNED FOR THIS INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER'S REPORT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POSSIBLE MORPHINE OVER INFUSION. THE MORPHINE ORDERS WERE 1.4MG BOLUS, LOCK OUT 6 MINUTES, AND MAXIMUM 8 BOLUS INJECTION PER HOUR. THE PATIENT DEVELOPED RESPIRATORY FAILURE AND HAD TO BE RESUSCITATED. THE PATIENT WAS INTUBATED, RECEIVED MULTIPLE MEDICATIONS, AND WAS TRANSFERRED TO THE ICU. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2014 IN STABLE CONDITION. CUSTOMER DOES NOT SUSPECT PROGRAMMING OR DEVICE ERRORS BUT IS REQUESTING EVENT LOG REVIEW TO ENSURE DEVICE WAS PROGRAMMED AND WORKING CORRECTLY FROM 1400 TO 2359 ON (B)(6) 2014. MANUFACTURER'S REPORT NUMBER: 2016493-2014-00285. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359240 ALARIS PCA MODULE PCA INFUSION DEVICE FRN CAREFUSION CORP 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention BD 50 ML SYRINGE, MODEL/LOT UNK, THERAPY DATE:| ALARIS PCA MODULE TUBING, MODULE/LOT UNK| THERAPY DATE:| ALARIS PUMP MODULE, SN (B)(4), THERAPY DATE:| ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE TUBING, MODEL/LOT UNK| THERAPY DATE: