BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC

    MDR report key: 17985734 · Received October 23, 2023

    Report

    Report Number
    2015691-2023-16984
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    July 18, 2024
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXG
    UDI-DI
    00690103194593
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH IMAGE WAS PROVIDED FOR THIS COMPLAINT REPORTED AS FLOTRAC SYSTEM - BROKEN, SEPARATED AFTER IMAGE EVALUATION PERFORMED THE DEFECT COULD NOT BE CONFIRMED. REVIEWS OF THE DEVICE HISTORY RECORD, LOT HISTORY AND MANUFACTURING MITIGATIONS REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. AS SUCH, BASED ON AVAILABLE INFORMATION, A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. 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

    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. D2A COMMON DEVICE NAME: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. D2B DEVICE PRODUCT CODE: DXG.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE WAS DISCARDED. 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. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY 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 WHILE A NURSE WAS REPOSITIONING A PATIENT IT WAS NOTICED THAT THE FLOTRAC ARTERIAL TUBING CAME APART AT THE CONNECTION BELOW THE TRANSDUCER. NO HARM TO PATIENT. IT WAS CAUGHT IMMEDIATELY. IT WAS REPORTED THAT THE DEFECTIVE SAMPLE WAS DISCARDED BY CLINICIAN. PER THE CUSTOMER, THE CONNECTION THAT CAME APART WAS A NON BONDED CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128727 FLOTRAC COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES DR MHD65 64545511 00690103194593
    2301704 FLOTRAC COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES DR MHD65 64545511 00690103194593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown