BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 7736877 · Received July 31, 2018

    Report

    Report Number
    1219702-2018-00022
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    May 28, 2018
    Report Date
    July 31, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    10896128002760
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE ACTUAL DEVICE WAS NOT IDENTIFIED AT THE TIME OF THE EVENT, THE HOSPITAL BIOMED TESTED ALL FOUR IN-HOUSE UNITS AND FOUND THAT NONE OF THEM REPLICATED THE ISSUE OF NOT EXHIBITING A HIGH PRESSURE ALARM. NONE OF THE RAPID INFUSERS HAVE BEEN RETURNED TO BELMONT FOR INVESTIGATION. WITHOUT ADDITIONAL INFORMATION OR IMAGES, IT IS DIFFICULT TO DETERMINE WHAT OCCURRED IN THIS INCIDENT. FOLLOWING A TELEPHONE CALL WITH HOSPITAL RISK MANAGEMENT, IT WAS DETERMINED THAT THE PATIENT HAD RECOVERED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE REPORT SUBMITTED BY THE USER FACILITY STATED: "PATIENT ADMITTED TO THE HOSPITAL SECONDARY TO WOUNDS TO THE ABDOMEN, RESULTING IN INJURIES TO THE RIGHT UPPER DIAPHRAGM, LIVER AND RIGHT KIDNEY. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, REPAIR OF THE DIAPHRAGM INJURY, BLEEDING CONTROL OF THE LIVER AND RIGHT KIDNEY, AND RIGHT TUBE THORACOSTOMY. AT THE CONCLUSION OF THE EXPLORATORY LAPAROTOMY, THE LEFT RADIAL ARTERIAL LINE WAS NOT FUNCTIONING. THE LEFT BRACHIAL IV WAS FOUND TO BE INFILTRATED. COMPARTMENTS OF THE PATIENT'S FOREARM AND ARM WERE FOUND TO BE TAUT. AN EMERGENCY FASCIOTOMY WAS PERFORMED. VOLAR LEFT FOREARM AND LATERAL ARM FASCIOTOMIES WERE PERFORMED IN A Z FASHION ACROSS THE BRACHIAL FOSSA. AT THE TIME OF THE INFUSION DURING THE EXPLORATORY LAPAROTOMY, A BELMONT RAPID INFUSION DEVICE WAS IN USE. ALLEGEDLY THE BELMONT RAPID INFUSION DEVICE DID NOT ALARM WHEN HIGH PRESSURES DEVELOPED DURING THE PROCEDURE. THE ACTUAL DEVICE WAS NOT IDENTIFIED AT THE TIME OF THE EVENT . THEREFORE, ALL 4 IN HOUSE UNITS WERE TESTED BY THE BIOMEDICAL DEPARTMENT. NONE REPLICATED THE ISSUE OF NOT ALARMING WHEN PRESSURE BECAME TOO HIGH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578584 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC RI-2 10896128002760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention