BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3802886 · Received April 30, 2014

    Report

    Report Number
    2016493-2014-00225
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HOSPITAL INTERNAL INVESTIGATION FOUND THAT THE CAUSE OF THE OVER INFUSION WAS DUE TO A PROGRAMMING ERROR THAT OCCURRED WHEN A NEW DOSE WAS ADDED. NO FURTHER INVESTIGATION IS REQUIRED FROM CAREFUSION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PCA OVER INFUSION OF MORPHINE. PATIENT WAS FOUND SOMNOLENT AND REQUIRED A NARCAN DRIP AT 0440 AND WAS TRANSFERRED TO THE ICU FROM THE MED/SURG UNIT. NARCAN DRIP WAS DISCONTINUED AT 1024 ON (B)(6) 2014. ALTHOUGH REQUESTED, NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258075 ALARIS PCA MODULE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PCS ADMINISTRATION SET: MFR/MODEL/LOT UNK| SYRINGE: MFR/MODEL/LOT UNK| ALARIS PC UNIT: SN (B)(4)