BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3252339 · Received July 24, 2013

    Report

    Report Number
    MW5031078
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 9, 2013
    Report Date
    July 17, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE CASSETTE THAT CONNECTS TO THE PUMP IS NOT WORKING CORRECTLY WITH THE PUMP. THE CASSETTE CAN BE CONNECTED, BUT AS SOON AS IT IS AND THE PUMP IS LOCKED, THE PUMP ALARMS AND SAYS "WRONG CASSETTE." THIS HAS HAPPENED ON MULTIPLE PUMPS. NOT ONLY HAS THIS OCCURRED WITH PHARMACY STAFF, BUT THIS HAS ALSO HAPPENED TO PTS DURING PT USE. ONE SPECIFIC INCIDENT WAS DOCUMENTED OF A PT CALLING THE NURSE BECAUSE THE PUMP WAS ALARMING AND READ "WRONG CASSETTE." THE NURSE HAD THE PT REMOVE THE CASSETTE AND CONNECT IT AGAIN, AND THE NEXT MESSAGE GIVE WAS "CASSETTE DAMAGED FREE FLOW MAY OCCUR." THE PT TRIED TO CONNECT 2 DIFFERENT BAGS/CASSETTES WITH THE SAME RESULT. THE PT WAS INSTRUCTED TO UNLOAD/RELOAD THE CASSETTES AND CHANGE THE BATTERY IN THE PUMP. THIS STILL DID NOT SOLVE THE PROBLEM. THIS IS NOT A PUMP ERROR, AS THIS ONLY OCCURS WHEN THIS TYPE OF TUBING IS CONNECTED. THE SUSPICION IS THAT THERE MAY BE AN ISSUE IN THE MOLDING OF THE CASSETTE. THIS HAS HAPPENED MULTIPLE TIMES SINCE MAY AND IS STILL CONTINUING. THE SPECIFIC LOT NUMBER IS UNK AS LOT NUMBERS BEING DISPENSED WITH THE PUMP ARE NOT TRACKED. THIS MAY BE HAPPENING WITH MULTIPLE LOT NUMBERS. WE HAVE NOTIFIED THE MANUFACTURER ONCE ON (B)(4) 2013 OF THIS MALFUNCTION AND A SAMPLE OF THE DEFECTIVE TUBING WAS SHIPPED. THE LOT NUMBER FOR THE TUBING SENT IN WAS 43X156. AS STATED EARLIER THOUGH, LOTS ARE NOT TRACKED WHEN BEING DISPENSED WITH THE PUMP. MULTIPLE LOTS MAY BE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344383 NA CADD ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. MULTIPLE LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1