BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3760826 · Received April 7, 2014

    Report

    Report Number
    2016493-2014-00176
    Event Type
    Injury
    Date Received
    April 7, 2014
    Report Date
    March 17, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OPEN HEART SURGERY PATIENT WAS CONNECTED TO A PUMP THAT ALARMED AND EXPERIENCED A LOSS OF COMMUNICATION WITH THE PCU. THE PATIENT WAS ON MULTIPLE DRIPS AND WHEN THE EVENT OCCURRED THE USER POWER CYCLED THE SYSTEM AND SUBSEQUENTLY REPROGRAMMED ALL INFUSIONS. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY AS A RESULT. NO FURTHER EVENT OR PATIENT INFO PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205722 ALARIS PC UNIT FRN CAREFUSION CORP 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE ADMIN SETS, MODEL/LOT UNK| ALARIS PUMP MODULE, SERIAL # UNK