BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFF (MARK I) VOLUMTRIC INFUSION PUMP

    MDR report key: 1180871 · Received September 22, 2008

    Report

    Report Number
    3006467056-2008-00001
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 15, 2008
    Manufacturer
    TYLA MEDICAL SYSTEMS
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A CORRECTIVE ACTION, THE SOFTWARE OF THE DEVICE HAS NOW BEEN MODIFIED SO THAT THE DEVICE WILL DETECT IF THE COMPONENT IS FUNCTIONING PROPERLY AND WILL AUDIBLY AND VISUALLY ALERT THE OPERATOR OF ANY COMPONENT MALFUNCTION. IN THIS CASE, IN PLAIN CONTRADICTION OF THE DEVICE OPERATING INSTRUCTIONS, WHICH ALSO CLEARLY APPEAR ON THE SIDE OF THE PUMP, THE OPERATOR PROGRAMMED IT TO CONTINUE PUMPING PAST DEPLETION OF THE CONTENTS OF THE INFUSION BAG, THUS DRAWING AIR INTO THE TUBE WHEN THE CONTENTS WERE DEPLETED. THUS, TWO FAILSAFE MECHANISMS WHICH WOULD HAVE PREVENTED THIS PHENOMENON, WERE CIRCUMVENTED: AUTOMATIC END OF INFUSION WHEN THE BAG WAS EMPTY, AND THE NEAR-END OF BAG ALERT TO THE OPERATOR TO PAY ATTENTION TO THE IMMINENT END OF THE BAG CONTENTS. A FURTHER FAILSAFE COMPONENT: A MICROPROCESSOR ATTACHED TO AN AIR SENSOR, WHICH IS DESIGNED TO DETECT THE PRESENCE OF AIR FAILED AND NO ALERT WAS PROVIDED OF THE PRESENCE OF AIR. THE SOFTWARE FOR THE DEVICE HAS BEEN MODIFIED SO THAT THE DEVICE WILL NOW DETECT IF A COMPONENT IS NOT FUNCTIONING AND IN SUCH CASE WILL ALERT THE USER OF THE MALFUNCTION TO "SYSTEM ERROR". THIS WILL ENSURE THAT IF THE FAILSAFE MECHANISM OF THE MICROPROCESSOR IS NOT FUNCTIONING, THAT THE OPERATOR IS ALERTED TO THIS FACT. THIS WILL PROVIDE INSURANCE FOR THE FAILSAFE MECHANISM AGAINST MALFUNCTION. IT SHOULD BE NOTED THAT IN THIS CASE THE AIR BUBBLE WAS NOTICED BY THE OPERATOR WHO WAS ADMINISTRATING THE TREATMENT. THERE WAS NO INJURY TO THE PATIENT OR ANY OTHER ADVERSE EVENT AND WE WOULD EXPECT THE LIKELIHOOD OF ANY SUCH EVENT TO BE VERY REMOTE. NEVERTHELESS, WE ARE IMPLEMENTING THE PROGRAMMING CHANGE IMMEDIATELY ON SITE FOR ALL DEVICES AND FOLLOWING VALIDATION ALL REPROGRAMMING WILL BE COMPLETED WITHIN TWO MONTHS FROM THIS DATE.

    Description of Event or Problem · 1

    AN ADMINISTRATOR IN THE USER FACILITY PROGRAMMED THE INFUSION PUMP TO DELIVER MORE THAN THE VOLUME OF CONTENTS IN THE INFUSION BAG IN ORDER TO BYPASS THE AUDIBLE "NEAR END" INDICATOR (MISUSE IN THE VIEW OF THE MANUFACTURER, BASED ON THE INSTRUCTIONS FOR USE). AS A RESULT, THE PUMP CONTINUED TO OPERATE PAST THE TIME THE CONTENTS OF THE BAG HAD BEEN DEPLETED, THEREBY CAUSING AIR TO ENTER THE INFUSION TUBE. THIS AIR WAS NOTICED BY THE OPERATOR, THE DEVICE WAS STOPPED, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR OBSERVATION TO CONFIRM THAT NO ADVERSE EVENT HAD OCCURRED. THE DEVICE FAILED TO ALERT TO THE PRESENCE OF AIR IN THE TUBE. THE MISUSE AND CIRCUMVENTION OF THE OPERATING INSTRUCTIONS BY THE OPERATOR INCAPACITATED TWO INDEPENDENT FAIL-SAFE MECHANISMS WHICH WOULD HAVE PREVENTED AIR FROM ENTERING THE TUBE: THE AUTOMATIC ENDING OF THE INFUSION WHICH WOULD HAVE CAUSED THE DEVICE TO STOP INFUSING WHEN THE BAG CONTENTS WERE DEPLETED, THUS NOT SUCKING IN AIR; THE AUDIBLE ALERT WHICH WOULD HAVE SOUNDED WHEN THE BAG NEARED ITS END, WHICH WOULD HAVE CAUSED THE OPERATOR TO STOP THE DEVICE. HAD IT NOT BEEN MISUSED, THE AIR WOULD NOT HAVE ENTERED THE TUBE. ON EXAMINATION OF THE DEVICE BY THE MANUFACTURER, IT WAS OBSERVED THAT THE PROCESSOR WHICH WAS DESIGNED TO ALERT FOR THE REMOTE POSSIBILITY OF AIR IN THE TUBE, HAD MALFUNCTIONED AND WAS NOT OPERATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFF (MARK I) VOLUMTRIC INFUSION PUMP INFUSION PUMP FRN TYLA MEDICAL SYSTEMS TR-1400

    Patients

    Seq Age Sex Outcome Treatment
    1