BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2853964 · Received October 24, 2012

    Report

    Report Number
    2016493-2012-00451
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CARDIZEM OVER INFUSION IN THE ICU. A NURSE HUNG A NEW BAG OF CARDIZEM ON (B)(6) 2012 AT 1910 AND STARTED THE INFUSION AT 15 MG/HOUR (15ML/ HOUR) AND VOLUME TO BE INFUSED WAS 125 ML. AT 2000 THE PUMP MODULE ALARMED TO ADD MORE VOLUME TO BE INFUSED AND THE NURSE FOUND THE CARDIZEM BAG EMPTY. THE NURSE DID NOT NOTICE ANY IV TUBING LEAKS. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION OCCURRED. CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE. MANUFACTURER'S REPORT NUMBER: 2016493-2012-00451. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN THERAPY DATE| LOT# UNKNOWN| THERAPY DATE| ALARIS PUMP MODULE ADMIN SET, MODEL UNKNOWN| ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)