BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 4009336 · Received July 30, 2014

    Report

    Report Number
    2016493-2014-00357
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES RECEIVED, LOG REVIEW ONLY. THE CUSTOMER'S REQUEST FOR A LONG REVIEW WAS COMPLETED; HOWEVER, NO DEVICE MALFUNCTION HAS BEEN ALLEGED. REVIEW OF THE PCU DEVICE LOGS CONFIRMED ON (B)(6) 2014 AT 10:15 PM THE USER PROGRAMMED THE PCA DEVICE USING GUARDRAILS DRUGS FOR THE DRUG FENTANYL AS A STANDARD CONCENTRATION (10MCG/ML) AND STARTED THE INFUSION. BETWEEN 10:17 PM AND 6:17 AM ON (B)(6) 2014, A TOTAL OF 12 PCA DOSES WAS DELIVERED. ON (B)(6) 2014, AT 2:20PM, THE USER BEGAN PROGRAMMING ANOTHER FENTANYL INFUSION AS A STANDARD CONCENTRATION (10MCG/ML); HOWEVER, THE DRUG SELECTION WAS CANCELLED. THE USER THEN SELECTED FENTANYL AS A HIGH DOSE CONCENTRATION (50MCG/ML), PCA ONLY, AND STARTED THE INFUSION. BETWEEN 2:33 PM AND 6:08 AM ON (B)(6) 2014, 73 PCA DOSES WERE DELIVERED. THE USER CHANGED THE FENTANYL BACK TO STANDARD CONCENTRATION (10MCG/ML) ON (B)(6) 2014, AT 6:10 AM. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS USER PROGRAMMING.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED AN EVENT LOG REVIEW TO DETERMINE A DRUG ID AND IF AND WHEN THERE WAS A PCA CONCENTRATION CHANGE ON FENTANYL FROM 10MCG/ML TO 50MCG/ML. THE CUSTOMER REPORTED THE INTENDED CONCENTRATION WAS 10 MCG/ML. SOMETIME DURING THE INFUSION, THE CONCENTRATION WAS CHANGED TO 50 MCG/ML, RESULTING IN SIGNIFICANTLY LOWER DOSE PER PCA REQUEST CAUSING AN UNDER INFUSION. THE PATIENT THEN REQUESTED ADDITIONAL CLINICIAN ADMINISTERED DOSES. THE PHYSICIAN WAS ALERTED AND THE INFUSION WAS REPROGRAMMED TO THE INTENDED CONCENTRATION OF 10 MCG/ML. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444388 ALARIS PCA MODULE PCA INFUSION DEVICE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT, SN: (B)(4)| PUMP MODULE, SN: (B)(4)| ALARIS PUMP MODULE TUBING X2, MODEL/LOT: UNK| PUMP MODULE, SN: (B)(4)| BD 30ML SYRINGE, MODEL/LOT: UNK| ALARIS PCA MODULE TUBING, MODEL/LOT: UNK