BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEBREAK VASCULAR

    MDR report key: 20941489 · Received December 16, 2024

    Report

    Report Number
    3019511659-2024-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 17, 2025
    Manufacturer
    LINEUS MEDICAL
    Product Code
    QOI
    UDI-DI
    10860635000311
    PMA / PMN Number
    DEN190043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. DHR REVIEW CONFIRMED NO MANUFACTURING DEVIATIONS AND REVIEW OF COC CONFIRMED FEMALE LUER WAS WITHIN SPECIFICATION. ANALYSIS OF THE COMPLAINANT DEVICE COULD NOT BE COMPLETED. UNABLE TO DETERMINE IF LEAK WAS THE RESULT OF THE DEVICE ITSELF OR IMPROPER CONNECTION OF THE DEVICE WITH THE ADMINISTRATION TUBING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PROBLEM: LEAKS FROM THE END OF THE SAFEBREAK DEVICE & THE IV TUBING EVENT: (SPECIFIC DATE NOT PROVIDED). A NURSE REPORTED THAT WHILE MANAGING A PATIENT REQUIRING AN INSULIN INFUSION (INSULIN GTT) VIA GLUCOMMANDER, A LEAKING INTRAVENOUS (IV) CONNECTION WAS OBSERVED. UPON ENTERING THE PATIENT'S ROOM TO COSIGN A NEW BAG OF INSULIN, SHE NOTICED THE PATIENT HAD A PILLOW UNDER THEIR ARM, WHICH WAS SOAKED. THE INSULIN INFUSION WAS RUNNING THROUGH AN IV IN THE SAME ARM. THE ATTENDING NURSE REPORTED ONGOING LEAKAGE FROM THE IV SETUP, WHICH INCLUDED A SAFEBREAK DEVICE. UPON ASSESSING THE IV, SHE CONFIRMED THAT THE LEAKAGE ORIGINATED FROM THE END OF THE SAFEBREAK. AS A RESULT OF THIS LEAKAGE, THE GLUCOMMANDER SYSTEM DETECTED RISING BLOOD GLUCOSE LEVELS AND AUTOMATICALLY INCREASED THE INSULIN INFUSION RATE TO COMPENSATE, EVENTUALLY REACHING A HIGH DOSE. AFTER DISCONNECTING THE SAFEBREAK, THE INSULIN INFUSION RATE DECREASED, AND THE PATIENT'S GLUCOSE LEVELS STABILIZED.

    Description of Event or Problem · 0

    PATIENT REQUIRED AN INSULIN GTT USING GLUCOMMANDER. HIS NURSE ASKED ANOTHER NURSE TO CO-SIGN A NEW BAG OF INSULIN. UPON ENTERING THE ROOM, THE CO-SIGNING NURSE INSPECTED THE INSULIN GTT IV AND NOTED THAT THE PILLOW UNDER THAT SAME ARM WAS WET. THE PRIMARY NURSE TOLD THE CO-SIGNING NURSE THAT SHE WAS HAVING A LEAKING ISSUE WITH THE IV. WHEN THE CO-SIGNING NURSE ASSESSED THE IV, SHE NOTED IT WAS LEAKING FROM THE END OF THE SAFEBREAK THAT CONNECTS TO THE ADMINISTRATION LINE. THE GLUCOMMANDER HAD STARTED INCREASING THE INSULIN GTT UP TO A HIGHER DOSE BECAUSE THE PATIENT'S BLOOD SUGAR WAS INCREASING. THE NURSES REMOVED SAFEBREAK FROM THE ADMINISTRATION LINE, RECONNECTED THE ADMINISTRATION LINE TO THE PATIENT'S IV AND THE INSULIN GTT DOSE WENT BACK DOWN. THERE WAS NO REPORT OF PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. DEVICE WAS DISCARDED, BUT THE SITE REPORTED THAT THERE WERE NO VISIBLE BREAKS OR CRACKS BEFORE DISCARDING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312045 SAFEBREAK VASCULAR SAFEBREAK VASCULAR QOI LINEUS MEDICAL 11956 ,12025 10860635000311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown