BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 6957760 · Received October 18, 2017

    Report

    Report Number
    1219702-2017-00004
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    May 5, 2017
    Report Date
    October 18, 2017
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    UDI-DI
    10896128002760
    PMA / PMN Number
    K141654
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, WE RECEIVED MEDWATCH UF/IMPORTER REPORT #(B)(4), REGARDING AN INCIDENT INVOLVING THE KEY RATE SENSITIVITY ON THE TOUCH SCREEN OF A RAPID INFUSER, RI-2. THE INITIAL REPORTER STATED THAT THE KEY RATE WAS SET TO "LOW", WHICH IS THE SLOWEST RESPONSE RATE, THEREFORE RENDERING THE DEVICE "ALMOST UNUSABLE". THE INITIAL REPORTER ALSO NOTED THAT THE KEY RATE OF THE RI-2 IS DETERMINED BY RELEASE OF THE KEY, WHILE THE KEY RATE OF THE PREVIOUS RAPID INFUSER MODEL, THE FMS2000, WAS DETERMINED BY DEPRESSION OF THE KEY. IN SUBSEQUENT CORRESPONDENCE, AN MGH BIOMED EXPLAINS THAT THE EVENT WAS CAUSED BY USER MISINFORMATION. THE KEY RATE ON THE RI-2 IS SET AT THE FACTORY TO "MEDIUM". THEREFORE, THE "LOW" SETTING THE USER COMPLAINED ABOUT WAS SET BY SOMEONE OTHER THAN THE MANUFACTURER. THE RESPONSE TO THE MDR WAS DELAYED BECAUSE WE WANTED TO INCLUDE THE RESULTS OF THE EXAMINATION OF THE UNIT; HOWEVER, DESPITE MULTIPLE REQUESTS, WE DID NOT RECEIVE IT BACK UNTIL (B)(6). (WHEN WE REQUESTED THE UNIT FOR EVALUATION, THE USER FACILITY REQUESTED A LOANER, WHICH THEY RECEIVED ON (B)(6) 2017. THEY SUBSEQUENTLY INFORMED THE BELMONT SALES REPRESENTATIVE THAT THE LOANER UNIT WAS IN BIOMED FOR INSPECTION AND STATED, "ONCE THE UNIT HAS BEEN INSPECTED, CATALOGUED, AND LABELED AS A LOANER UNIT, IT CAN BE DEPLOYED TO THE SICU, THEN THE SICU UNIT CAN BE RETURNED." ON (B)(6) 2017, THE BELMONT SALES REPRESENTATIVE FOLLOWED UP WITH THE USER FACILITY AS THEY STILL HAD NOT RELEASED THE IMPLICATED UNIT FROM SICU TO BE SENT TO BELMONT FOR INVESTIGATION. THE BIOMED STATED THAT HE HAD JUST HEARD BACK FROM HIS RESOURCE TECHNICIAN, AND SAID IT WOULD MOST LIKELY BE A COUPLE OF DAYS BEFORE THEY COULD CLEAR THE LOANER UNIT FOR THE SICU.) WHEN THE UNIT WAS RECEIVED BACK FOR EVALUATION, THE KEY RATE WAS SET TO "FAST", WHICH WAS AGAIN A SETTING INITIATED BY SOMEONE OTHER THAN THE MANUFACTURER. WHEN THE UNIT WAS INVESTIGATED BY BELMONT FOLLOWING ITS RETURN, THERE WERE NO ISSUES DETECTED. THE REPORT FROM THE USER FACILITY ALSO COMPLAINS ABOUT A CHANGE IN THE KEY ACTIVATION MECHANISM FROM BEING ACTIVATED BY A DEPRESSION TO BEING ACTIVATED BY A RELEASE. THIS CHANGE WAS MOTIVATED BY ANSI/AAMI HE75:2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES, WHICH STATES, "UP-TRIGGERS" (ACTIVATION UPON RELEASE) ARE GENERALLY PREFERABLE TO "DOWN-TRIGGERS" (ACTIVATION UPON INITIAL TOUCH) BECAUSE ACTIVATION UPON RELEASE OF THE FINGER DECREASES ERRORS." THE MGH CORRESPONDENCE ALSO ACKNOWLEDGES THAT THIS ERROR WAS CAUSED BY THEIR ALLOWING A TEAM THAT WAS UNFAMILIAR WITH THE MACHINE TO USE IT. WE RESPONDED WITH ADDITIONAL TRAINING.

    Description of Event or Problem · 1

    THE REPORT FROM THE USER FACILITY STATED: "THE "KEY RATE" OPTION SETS A DELAY ON THE SENSITIVITY OF THE TOUCH KEYS WHICH REQUIRES THE USERS TO HOLD ANY KEY FOR MUCH LONGER THAN USUAL. THE KEY RATE ON THE BELMONT RI-2 WAS SET TO LOW WHICH IS THE SLOWEST RESPONSE, FRIGHTENINGLY ALMOST UNUSABLE. EACH KEY RATE HAS A SPECIFIC LATENCY AND IS DETERMINED BY THE USER'S RELEASE OF THE KEY INSTEAD OF DEPRESS (OLD BELMONT FMS2000). THAT IS WHY HOLDING THE KEYS DOWN FOR LONGER WILL NOT ACTIVATE ANY FUNCTION ON THE NEW BELMONT RI-2. REPORTED BY THE USER: WHEN SET TO LOW ON THE ORIGINAL BELMONT, THE DEVICE IS A LITTLE SLOWER TO RESPOND TO CLICKS AS INTENDED, BUT IS STILL EASY TO USE. HOWEVER, WHEN THE RI-2 IS SET TO LOW, THE DEVICE IS ALMOST UNUSABLE. IT WAS VERY FRIGHTENING TO HAVE A BELMONT FULL OF BLOOD WHICH WE COULD NOT UTILIZE DURING AN EMERGENT TAKE-BACK FOR BLEEDING. IF AN "ORIGINAL" BELMONT HAD NOT BEEN IMMEDIATELY AVAILABLE (WE TRANSFERRED THE SAME CANISTER/TUBING FROM THE RI-2 DIRECTLY TO THE ORIGINAL), THE PATIENT MAY HAVE EXPERIENCED AN ADVERSE OUTCOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739289 THE BELMONT RAPID INFUSER WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION RI-2 10896128002760

    Patients

    Seq Age Sex Outcome Treatment
    1