BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3964860 · Received July 16, 2014

    Report

    Report Number
    2016493-2014-00327
    Event Type
    Injury
    Date Received
    July 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE NITROGLYCERIN WAS HANGING, A CHANNEL ERROR/"CHECK IV SET" CAME UP AS SOON AS THE CHANNEL WAS TURNED ON. THE USER TURNED OFF THE CHANNEL AND OPENED THE DOOR BUT THE SAFETY CLAMP FITMENT DIDN'T CLOSE, SO THE "FLUID FREE FLOWED". REPORTEDLY, THERE WAS A TRANSIENT DROP IN THE PATIENT'S BLOOD PRESSURE. THE PATIENT WAS GIVEN A FLUID CHALLENGE AND WAS TRANSFERRED TO THE CATH LAB AS ORIGINALLY SCHEDULED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416087 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE ADMINISTRATION SET,| MODEL/LOT UNKNOWN| ALARIS PC UNIT, SN UNKNOWN