BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4298229 · Received November 21, 2014

    Report

    Report Number
    2016493-2014-00535
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Report Date
    October 29, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT SEQUESTERED BY THE CUSTOMER. BECAUSE THE CUSTOMER DID NOT RECORD THE DEVICE SERIAL NUMBER AND NO DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED. NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD MULTIPLE ALARIS CHANNELS STOP WORKING SUDDENLY. IN ONE INSTANCE THE CUSTOMER REPORTED: "I JUST HAD MULTIPLE ALARIS CHANNELS STOP WORKING SUDDENLY WHEN I TOUCHED A CHANNEL TO PAUSE THE PROTAMINE INFUSION IN RESPONSE TO SUDDEN HYPOTENSION WITH PRESSURES IN THE 30'S. EARLIER IN THE CASE, THE NTH CHANNEL SOMEHOW SPONTANEOUSLY TURNED ITSELF BACK ON AFTER IT HAD BEEN PAUSED." THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758543 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL/LOT #S: UNK| ALARIS PC UNIT, SN: UNK| ALARIS PUMP MODULE ADMINISTRATION SET,