BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3802888 · Received April 30, 2014

    Report

    Report Number
    2016493-2014-00235
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SMOKE WAS VISUALIZED COMING OUT FROM BETWEEN THE PC UNIT AND PUMP MODULE DURING AN INFUSION. THE PRIMARY WAS 1000ML BAG OF LACTATED RINGERS AND THE SECONDARY HAD A BOTTLE OF TYLENOL. A PCA MODULE WAS ATTACHED ON THE OTHER SIDE OF THE PC UNIT AND HAD NO ISSUES. THERE WAS NO PATIENT HARM. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258156 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE: SN (B)(4)| THERAPY DATE:| ALARIS PCA MODULE: SN UNK| ALARIS ADMIN SETS: MODELS/LOTS UNK