BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC MODULE

    MDR report key: 3023255 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00131
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED AND THAT THE HOSPITAL WILL CONDUCT THEIR OWN INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER'S REPORTED OVERINFUSION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERINFUSION OF DILAUDID. DETAILS OF THE EVENT WERE REPORTED AS FOLLOWS: THE PT WAS ON DILAUDID PCA, CONCENTRATION OF 0.2 MG/ML. INTENDED PROGRAMMING WAS 0.2 MG PCA, 10 MIN LOCKOUT, 0.4 MG BOLUS DOSE, 5 MG/4 HOUR LIMIT. THE ENTIRE SYRINGE OF 5 MG DILAUDID WAS FOUND EMPTY IN JUST UNDER TWO HOURS. APPEARS THAT THE PT GOT ABOUT TWO TIMES THE INTENDED AMOUNT. THERE WAS NO PT HARM. THE PT WAS "FEELING PRETTY GOOD". NO MEDICAL INTERVENTION WAS NEEDED. THE CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84759 ALARIS PC MODULE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| THERAPY DATE:| ALARIS PC ADMINISTRATION SET: MODEL/LOT NUMBER UNK