BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC, VAMP

    MDR report key: 17970721 · Received October 19, 2023

    Report

    Report Number
    2015691-2023-16939
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    October 1, 2023
    Report Date
    July 19, 2024
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXG
    UDI-DI
    00690103194722
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THE FOLLOWING ARE ADDITIONAL PRODUCT CODES FOR THIS DEVICE: DRS TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR. DQE CATHETER, OXIMETER, FIBEROPTIC. THE FOLLOWING IS CORRECTED DATA, AS THE ORIGINAL IDENTIFICATION INFORMATION SENT DID NOT MATCH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID): D1 BRAND NAME: FLOTRAC, VAMP. D2A COMMON DEVICE NAME: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. D2B DEVICE PRODUCT CODE: DXG.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT HOSPITAL. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. FURTHER EVALUATION REGARDING RELATED QUALITY ISSUES IS UNDER INVESTIGATION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FLOTRAC DEVICE HAD INACCURATE BLOOD PRESSURE VALUES. FLOTRAC WAS ATTACHED TO A HEMOSPHERE AND NON EDWARDS BEDSIDE MONITOR, GE HEALTHCARE. CLINICIAN NOTED THAT THE FLOTRAC DISPLAYED UNEXPECTED SPIKES IN THE BLOOD PRESSURE READINGS. EXCHANGING THE DEVICE RESOLVED THE ISSUE. NO PATIENT INJURIES. USED DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203631 FLOTRAC, VAMP COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES DR MHD6AZ 64922040 00690103194722
    2200706 FLOTRAC, VAMP COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES DR MHD6AZ 64922040 00690103194722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown