BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 11988151 · Received June 11, 2021

    Report

    Report Number
    1219702-2021-00080
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    April 23, 2021
    Report Date
    June 11, 2021
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    LGZ
    UDI-DI
    00896128002800
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RAPID INFUSER, RI-2 WAS RETURNED TO BELMONT FOR INVESTIGATION. THE REPORTED FAILURE WAS NOT EASILY REPLICATED, HOWEVER AFTER EXTENSIVE TESTING BY CONTINUOUSLY PRESSING VARIOUS BUTTONS ON THE SCREEN FOR 1-2 HOURS, IT WAS CONFIRMED THAT THE DISPLAY BECAME FROZEN. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED, BELMONT UPGRADED THE SYSTEM TO THE CURRENT REVISION. THE UNIT SUBSEQUENTLY PASSED ALL TEST SPECIFICATIONS AND INSPECTION REQUIREMENTS. AS NO ROOT CAUSE WAS IDENTIFIED, A HEALTH HAZARD ANALYSIS WAS CONDUCTED TO ASSESS THE LEVEL OF RISK ASSOCIATED WITH AN UNRESPONSIVE TOUCH SCREEN. IT WAS DETERMINED THAT THE FREQUENCY OF OCCURRENCE IS LOW AND THE BENEFITS OF USING THE RI-2 DEVICE FAR OUTWEIGH THE RISK OF THIS TYPE OF MALFUNCTION. THE MOST SERIOUS RISK OF AN UNRESPONSIVE TOUCH SCREEN IS A POTENTIAL DELAY IN TREATMENT, HOWEVER THIS MALFUNCTION WOULD BE IMMEDIATELY APPARENT TO THE USER. THE INSTRUCTIONS FOR USE STATE:"ROUTINELY CHECK PATIENT AND SYSTEM PARAMETERS, ON SCREEN. RESPOND TO AND CORRECT SYSTEM ALARMS." THE TROUBLESHOOTING GUIDE IN THE OPERATOR'S MANUAL PROVIDES POSSIBLE CONDITIONS AND RECOMMENDED OPERATOR ACTIONS IN THE EVENT THAT THE KEYPAD IS UNRESPONSIVE OR DOES NOT ACCEPT INPUT. THE MANUFACTURING RECORDS FOR THIS SERIAL NUMBER WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE, HOWEVER THE HYPOTENSION WAS NOTED PRIOR TO ANY ISSUES WITH THE DEVICE. BELMONT WILL CONTINUE TO MONITOR AND TREND SIMILAR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    THE BELMONT RAPID INFUSER, RI-2 HAS BEEN RETURNED TO BELMONT FOR INVESTIGATION; EVALUATION OF THE UNIT IS IN PROCESS. FLUID CONTAMINATION CAN CAUSE PROBLEMS WITH THE MEMBRANE SWITCH/CPU BOARD INTERFACE, HOWEVER WITHOUT RESULTS OF THE INVESTIGATION A ROOT CAUSE OF THE REPORTED UNRESPONSIVE TOUCH SCREEN AND FROZEN DISPLAY CANNOT BE ESTABLISHED. THE OPERATOR'S MANUAL CAUTIONS THE USER: "IMMEDIATELY WIPE ANY SPILLS FROM THE DEVICE." THE SERVICE AND PREVENTIVE MAINTENANCE SCHEDULE OUTLINED IN THE MANUAL INSTRUCTS THE USER TO CHECK THE UNIT SEALS EVERY SIX MONTHS. THE OPERATOR'S MANUAL ALSO OFFERS POSSIBLE CONDITIONS AND RECOMMENDED OPERATOR ACTIONS IN THE EVENT THAT THE KEYPAD IS UNRESPONSIVE OR DOES NOT ACCEPT INPUT. THE MANUFACTURING RECORDS FOR THIS SERIAL NUMBER WERE REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE, HOWEVER THE HYPOTENSION WAS NOTED PRIOR TO ANY ISSUES WITH THE DEVICE. A FINAL FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (REPORT NUMBER: 2021/004/029/291/013) FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) IN THE UK: "INFRARENAL AAA REPAIR. BELMONT RI-2 (1000ML/MIN VERSION) HAD BEEN WORKING FINE THROUGHOUT CASE. GRAFT IN SITU, LEGS REPERFUSED. SURGEONS DEALING WITH HAEMOSTASIS. SLOW OOZE FROM MULTIPLE SITES. FLUID AT 20ML/MIN VIA BELMONT. SLIGHT DROP IN BP, ATTEMPTED TO GIVE 200ML RAPID BOLUS BUT NO RESPONSE FROM BELMONT SCREEN. REGARDLESS OF BUTTON PRESSED, 20ML/MIN DISPLAYED. SCREEN BEEPED WHEN PRESS BUT NO APPARENT ACTION. ODP HELP REQUESTED BUT RAPID PRECIPITOUS DROP IN BP TO 60 SYSTOLIC. SURGEON MANUALLY CLAMPED AORTIC GRAFT WHILST FLUID RESUSCITATION GIVEN VIA ALTERNATIVE CANNULA AND VASOPRESSOR GIVEN. AFTER 2 X OFF/ON CYCLES BELMONT BECAME USABLE AGAIN. FURTHER EPISODE 10 MINUTES LATER. THIS TIME MORE CLEAR THAT BELMONT ACTUALLY RESPONDING TO SCREEN PRESSES, BUT DISPLAY TOTALLY FROZEN SO NO WAY TO CONFIRM CURRENT INFUSION RATE, PRESSURE ETC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884073 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT MEDICAL TECHNOLOGIES RI-2 00896128002800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown