BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIFILL I.V.

    MDR report key: 1632560 · Received March 4, 2010

    Report

    Report Number
    3004771245-2010-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 4, 2010
    Manufacturer
    FHT, INC.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTELLIFILL I.V. FILLS SYRINGES INSIDE AN AUTOMATION ENCLOSURE; THE AUTOMATION ENCLOSURE IS EQUIPPED WITH A HEPA FILTER TO PROVIDE CLEAN AIR FLOW TO ASSIST WITH CREATING AN ASEPTIC SYRINGE PROCESSING ENVIRONMENT. THE CUSTOMER SITE REPORTED ON (B)(6) 2010, THAT THEY NOTICED THE HEPA UNIT WAS NOT FUNCTIONING (BLOWING AIR) WHEN THEY WERE ATTEMPTING TO CERTIFY THE HEPA UNIT. PER THE CUSTOMER SITE INTERNAL INVESTIGATION, THEY BELIEVE THE HEPA UNIT WAS SHUT OFF BY CUSTOMER SITE PERSONNEL ON 1/22/2010, TO ALLOW ROUTINE PRE-FILTER REPLACEMENT ACTIVITY TO OCCUR. THEY BELIEVE THAT THE HEPA UNIT WAS NOT TURNED BACK ON FOLLOWING THE PRE-FILTER CHANGE. DURING THE TIME THE HEPA UNIT WAS BELIEVED TO BE TURNED OFF, THE CUSTOMER USED THE INTELLIFILL I.V. TO FILL SYRINGES. THE DEVICE OPERATOR FAILED TO NOTICE THAT THERE WAS NO AIR FLOW IN THE AUTOMATION ENCLOSURE WHILE PERFORMING SET UP AND DEVICE OPERATIONS. UPON DISCOVERING THE HEPA ISSUE, THE CUSTOMER QUARANTINED ALL SYRINGES MADE DURING THE SUSPECT TIME PERIOD, SO THEY COULD BE DISPOSITIONED APPROPRIATELY FOLLOWING THE INVESTIGATION. ALL SYRINGES WERE DISCARDED FOLLOWING THE INVESTIGATION; NONE OF THE SYRINGES WERE SENT TO HOSPITAL FLOORS FOR PATIENT USE. PER DESIGN, THE INTELLIFILL I.V. SOFTWARE CHECKS A SENSOR FOR THE HEPA UNIT TO DETERMINE IF AIR IS FLOWING. IF NO AIR IS DETECTED, THE SOFTWARE IS DESIGNED TO NOT ALLOW THE INTELLIFILL I.V. TO FUNCTION, AND NOTIFIES THE OPERATOR OF THE HEPA AIR FLOW PROBLEM. THE OPERATOR MUST CORRECT THE HEPA AIR FLOW ISSUE BEFORE THE SOFTWARE WILL ALLOW THE INTELLIFILL I.V. TO RESUME FILLING OPERATIONS. HOWEVER, IN THIS INSTANCE, THE INTELLIFILL I.V. FAILED TO DETECT THAT THERE WAS NO AIR FLOW. INVESTIGATION BY FHT PERSONNEL DETERMINED THAT THE SENSOR WAS DAMAGED; THE CASING FOR THE SENSOR WAS CRACKED AND ONE OF THE PROBES CRUSHED. THIS DAMAGE RESULTED IN THE SENSOR SENDING A FALSE POSITIVE SIGNAL, SO THE SOFTWARE RECEIVED A SIGNAL INDICATING THE HEPA UNIT HAD AIR FLOWING THROUGH IT WHEN IN FACT THERE WAS NONE. ADDITIONAL INVESTIGATION BY FHT PERSONNEL AND THE SENSOR MANUFACTURER INDICATES THAT THIS DAMAGE CANNOT BE CAUSED BY ORDINARY USE, AND BASED ON THE TIMELINE OF INTELLIFILL I.V. ACTIVITY, THIS DAMAGE WAS NOT THE RESULT OF FHT PERSONNEL ACTIVITY. THIS DAMAGE WAS MOST PROBABLY CAUSED BY THE SITE PERSONNEL, HOWEVER, ORDINARY USE AND HANDLING OF THE INTELLIFILL I.V. ACCORDING TO THE INSTRUCTIONS FOR USE WOULD NOT HAVE CAUSED THIS DAMAGE. FHT IS EVALUATING DESIGN CHANGES TO MITIGATE THE POSSIBILITY OF RECURRENCE. FHT HAS ISSUED A CUSTOMER NOTIFICATION, INSTRUCTING CUSTOMERS TO TRAIN PERSONNEL TO OBSERVE THAT THERE IS AIR FLOW IN THE INTELLIFILL I.V., INDICATING THAT THE HEPA UNIT IS TURNED ON.

    Description of Event or Problem · 1

    SYRINGES WERE PREPARED IN AN AREA DESIGNED TO BE USED WHEN HEPA FILTERED AIR IS FLOWING, BUT IN THIS INSTANCE THE HEPA UNIT WAS NOT TURNED ON. THE DEVICE FAILED TO RECOGNIZE THIS AND NOTIFY TECHNICIAN OF THE LACK OF HEPA AIR FLOW. THE SYRINGES WERE QUARANTINED AND DESTROYED; NO SYRINGES WERE GIVEN TO PATIENTS AS DOSES. THERE WAS ONLY THE POTENTIAL FOR PATIENT ISSUES RESULTING FROM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIFILL I.V. PHARMACY COMPOUNDING DEVICE NEP FHT, INC. INTELLIFILL I.V. NA

    Patients

    Seq Age Sex Outcome Treatment
    1