BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 10308253 · Received July 22, 2020

    Report

    Report Number
    1018233-2020-04685
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. SYSTEM WENT THROUGH INITIAL FUNCTIONAL TEST WITHOUT AN ISSUE. AFTER OBSERVING THE SYSTEM LOG FILE IT IS DETERMINED THAT THE SYSTEM WENT THROUGH A LONG PERIOD OF OPERATION WITHOUT BEING PLUGGED INTO A POWER SOURCE AND THE REPORTED ISSUE COULD BE RELATED TO SYSTEM HAVING VERY LOW BATTERY. NO REPAIRS MADE. SERVICING OF THE UNIT WAS PERFORMED PER TEST PROCEDURE. THE DEVICE FUNCTIONED PROPERLY AND READY FOR USE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "THE SENSICA UO SYSTEM FOR ICU IS DESIGNED FOR PRECISE MEASUREMENT USING THE DISPOSABLE, SENSICA UO RING, WHICH IS PART OF THE SENSICA UO PATIENT RING KIT. EACH TIME THE SYSTEM IS USED WITH A NEW PATIENT, A NEW SENSICA UO RING MUST BE CONNECTED TO THE SENICA UO STAND. THE SYSTEM SOFTWARE IS DESIGNED TO CALIBRATE EACH TIME A NEW RING IS ATTACHED TO ENSURE ACCURATE CALCULATIONS OF URINE OUTPUT VOLUME." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SENSICA DEVICE WAS INACCURATELY MEASURING THE VOLUME GROSSLY FOR ABOUT 2 HOURS AND THE SENSICA UNIT WAS REMOVED FROM THE SERVICE. PER ADDITIONAL INFORMATION VIA E-MAIL ON 07JUL2020, THERE WAS AROUND 248ML IN THE BAG AS THE PATIENT'S URINE OUTPUT (UO) HAD BEEN 20-35ML/HR FOR 5 HOURS. EARLIER, NURSE HAD ADMINISTERED LASIX. AFTER DOING HER VITALS, THE BAG LEVEL HAD SIGNIFICANTLY INCREASED AND HAD AROUND 800ML IN THE BAG. THE BAG WAS DRAINED AND URINE OUTPUT WAS MEASURED. AT THE TIME, THERE WAS NO URINE ENTERING THE BAG SO SHE DRAINED THE BAG AND THEN CLAMPED THE FOLEY. AT THE BAG DRAIN/MEASUREMENT, THE NURSE'S MEASUREMENT COMPARED TO THE SYSTEM CONCLUDED THE SYSTEM WAS UNDER REPORTING UO BY SEVERAL HUNDRED ML'S. THE BAG WAS AGAIN DRAINED AND THE URINE OUTPUT WAS MEASURED. THE DEVICE UNDER REPORTED THE URINE OUTPUT BY APPROXIMATELY 150ML. NURSE ALSO STATED THAT INSTANT UPDATE BUTTON WAS NOT ACTIVE. NURSE THEN UTILIZED MANUAL METHODS FOR URINE OUTPUT MEASUREMENTS. NO PATIENT COMPLICATIONS WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SENSICA DEVICE WAS INACCURATELY MEASURING THE VOLUME GROSSLY FOR ABOUT 2 HOURS AND THE SENSICA UNIT WAS REMOVED FROM THE SERVICE. PER ADDITIONAL INFORMATION VIA E-MAIL ON 07JUL2020, THERE WAS AROUND 248ML IN THE BAG AS THE PATIENT'S URINE OUTPUT (UO) HAD BEEN 20-35ML/HR FOR 5 HOURS. EARLIER, NURSE HAD ADMINISTERED LASIX. AFTER DOING HER VITALS, THE BAG LEVEL HAD SIGNIFICANTLY INCREASED AND HAD AROUND 800ML IN THE BAG. THE BAG WAS DRAINED AND URINE OUTPUT WAS MEASURED. AT THE TIME, THERE WAS NO URINE ENTERING THE BAG SO NURSE DRAINED THE BAG AND THEN CLAMPED THE FOLEY. AT THE BAG DRAIN/MEASUREMENT, THE NURSE'S MEASUREMENT COMPARED TO THE SYSTEM CONCLUDED THE SYSTEM WAS UNDER REPORTING UO BY SEVERAL HUNDRED ML'S. THE BAG WAS AGAIN DRAINED AND THE URINE OUTPUT WAS MEASURED. THE DEVICE UNDER REPORTED THE URINE OUTPUT BY APPROXIMATELY 150ML. NURSE ALSO STATED THAT INSTANT UPDATE BUTTON WAS NOT ACTIVE. NURSE THEN UTILIZED MANUAL METHODS FOR URINE OUTPUT MEASUREMENTS. NO PATIENT COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776088 SENSICA UO MONITOR ICU SENSICA UO MONITOR ICU EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1