BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2052443 · Received March 15, 2011

    Report

    Report Number
    2016493-2011-00231
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    October 18, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S COMPLAINT OF A CHANNEL DISCONNECTED ALERT COULD NOT BE CONFIRMED. THE CUSTOMER WAS INSTRUCTED ON HOW TO USE THE RESTORE FEATURE, WAS PROVIDED WITH TIP SHEETS FOR ANESTHESIA MODE, AN ALARIS SYSTEM DFU AND CHANNEL ERROR REFERENCE MATERIAL. THE PUMPS WERE NOT SEQUESTERED AND ALTHOUGH 3 ATTEMPTS WERE MADE TO OBTAIN DEVICES, THE DEVICES WERE NOT RETURNED FOR INVESTIGATION. THE CAUSE OF THE CUSTOMER'S EXPERIENCE IS UNKNOWN. UPON FURTHER EVALUATION, WE HAVE DETERMINED THIS TO BE REPORTABLE.

    Description of Event or Problem · 1

    WHILE AT (B)(4) MEETING AN ANESTHESIOLOGIST REPORTED HE EXPERIENCES "CHANNEL DISCONNECTED" ALERTS WHEN DEVICES ARE BUMPED. NO DEVICE SAVED OR SEQUESTERED FOR REPORTED ISSUES. HE REPORTED THIS HAS HAPPENED APPROXIMATELY 10-12 TIMES. HE MUST REPROGRAM THE DEVICE WHEN THIS OCCURS. NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. HE REPORTS THIS OCCURS REGULARLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT: SERIAL NUMBER UNKNOWN