BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2853970 · Received October 24, 2012

    Report

    Report Number
    2016493-2012-00473
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 11, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE BIOMED TESTED THE PUMP AND DID NOT FIND ANYTHING WRONG. AT THIS TIME, THE BIOMED PLANS ON PUTTING THE DEVICE BACK INTO SERVICE SINCE THERE WERE NO PROBLEMS FOUND DURING TESTING. AN EVENT LOG REVIEW WAS REQUESTED HOWEVER THE LOGS AND DATA SET HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH RESULTS OF THE EVALUATION SHOULD THE LOGS BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CHEMOTHERAPY DRUG, DOCETAXEL, INFUSED IN 30 MINUTES INSTEAD OF THE EXPECTED 60 MINUTES. THE MEDICATION WAS MIXED IN 250 MLS OF SOLUTION. THE MEDICATION WAS HUNG AT 10:59, AND AT 11:29, THE DEVICE ALARMED FOR AIR IN LINE AND IT WAS AT THAT TIME THE NURSE NOTICED THE IV BAG WAS EMPTY. MAINTENANCE SOLUTION WAS INFUSED TO COMPLETE THE ONE HOUR TIME FRAME. IT WAS FURTHER REPORTED THAT THERE IS SOME SUSPICION THAT THE USER PROGRAMMED THE RATE AT 528 MLS INSTEAD OF 252 MLS. A LOG REVIEW WAS REQUESTED. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

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