BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3802865 · Received April 30, 2014

    Report

    Report Number
    2016493-2014-00236
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM ERROR WHILE A CRITICAL CARE PATIENT WAS BEING TRANSPORTED TO A TEST. TWO ALARIS SYSTEMS WERE ON ONE IV POLE; THE LOWER SYSTEM HAD 4 PUMP MODULES ATTACHED, WITH LEVOPHED INFUSING FOR BLOOD PRESSURE, PROPOFOL INFUSING FOR SEDATION AND TWO OTHER (UNSPECIFIED) MEDICATIONS INFUSING. WHILE IN THE ELEVATOR, THE LOWER PC UNIT ALARMED FOR SYSTEM ERROR AND SHUT DOWN, AND THE DEVICES COULD NOT BE POWERED BACK ON. THE PATIENT WAS TRANSPORTED BACK TO HIS ROOM, THE PUMPS WERE SWITCHED AND THE MEDICATIONS WERE RESTARTED. THE PATIENT HAD A TRANSIENT BLOOD PRESSURE DROP WHICH RECOVERED WITHIN 10 MINUTES OF RESTARTING THE LEVOPHED. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258074 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE (4): SNS (B)(4), (B)(4),| (B)(4), (B)(4)| ALARIS ADMIN SETS: MODELS/LOTS UNK