BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2990187 · Received February 6, 2013

    Report

    Report Number
    2016493-2013-00084
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER¿S CHEMO INFUSIONS FINISHING SOONER THAN ANTICIPATED. THE CUSTOMER STATED NO PUMPS OR SETS WERE SEQUESTERED THEREFORE NO EVAL COULD BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT WITH A CHEMO INFUSION ENDING EARLIER THAN ANTICIPATED. THE ALERT DATA HAS BEEN REVIEWED AND THEY DID NOT SEE ANY EVIDENCE THAT PROGRAMMING ERRORS WERE MADE. THIS EVENT OCCURRED ON THE INPATIENT ONCOLOGY UNIT, IN WHICH A 250 ML BAG OF 5FU INTENDED TO RUN AT 10.9 ML/HR OVER 24 HOURS, INSTEAD FINISHED 4 HOURS EARLY. THE INFUSION WAS A PRIMARY INFUSION AND THE SET WAS PRIMED WITH SALINE BY PHARMACY SO THERE SHOULD HAVE BEEN NO LOSS OF VOLUME WITH PRIMING. THEY HAVE CHECKED THEIR COMPOUNDER AND FOUND IT TO BE ACCURATE. CUSTOMER SAYS SHE RULED OUT THE POSSIBILITY OF MULTIPLE AIL ALARMS WHICH MIGHT HAVE NECESSITATED THE USER TO FLUSH FLUID THROUGH THE LINE TO GET BUBBLES OUT. THERE WAS NO REPORT OF PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADD¿L PATIENT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49799 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

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