BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3842552 · Received February 21, 2014

    Report

    Report Number
    2016493-2014-00104
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 4, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT WAS ALERT AND ORIENTED. A 20 MEQ KCL SECONDARY INFUSION PROGRAMMED TO INFUSE OVER 2 HOURS, BUT INFUSED IN LESS THAN 1 HOUR. PT COMPLAINED OF SEVERE BURNING AT THE IV SITE. THE SITE WAS SLIGHTLY RED AND PAINFUL, BUT HAD A GOOD BLOOD RETURN. THE NURSE PUT A WARM COMPRESS ON IT. THE NURSE MONITORED THE SITE FOR THE REST OF THE SHIFT. THE SITE WAS FINE AND THE PT'S PAIN WENT AWAY. THE DEVICES AND TUBING WILL BE RETURNED FOR INVESTIGATION. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109746 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL/LOT #UNK| ALARIS PC UNIT: SN (B)(4)