BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 19844874 · Received July 26, 2024

    Report

    Report Number
    2015691-2024-05701
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    March 6, 2024
    Report Date
    October 22, 2024
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: KRA, PRODUCT CODE NAME: CATHETER, CONTINUOUS FLUSH ADDITIONAL FDA PREMARKET SUBMISSION NUMBER:K181684, K896819. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE RESULTS BECOME AVAILABLE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    OUR PRODUCT EVALUATION LAB RECEIVED ONE SINGLE DPT VAMP PLUS KIT. DRY BLOOD WAS VISIBLE AT DISTAL TUBING CONNECTOR. THE CUSTOMER REPORT OF INACCURATE VALUES WAS NOT ABLE TO BE CONFIRMED. THE DPT SENSOR ZEROED AND SENSED PRESSURE ACCURATELY ON THE PRESSURE MONITOR. PRESSURE DID NOT SHOW ANY DRIFT DURING OUTPUT DRIFT TESTING AND MET SPECIFICATION. ELECTRICAL TESTING SHOWED THAT BOTH INPUT IMPEDANCE AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. THE T. ZERO OFFSET ALSO MET SPECIFICATION. NO LEAKAGE OR OCCLUSION WAS DETECTED FROM THE KIT DURING PRESSURE TEST. NO VISIBLE DAMAGE WAS OBSERVED FROM THE KIT. THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED, HOWEVER, THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE MALFUNCTION SUCH AS CONTINUOUS MONITORING SAMPLING, QA SAMPLING INSPECTION, 100% VISUAL INSPECTION, AND 100% ELECTRICAL TEST. THE INSTRUCTIONS FOR USE (IFU) STATES PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM, AND ABNORMAL PRESSURE READINGS SHOULD CORRELATE WITH THE CLINICAL MANIFESTATIONS OF THE PATIENT. INSTRUCTIONS INCLUDE TESTING DYNAMIC RESPONSE AND NOTES THAT POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. IT WARNS THAT MOISTURE WITHIN THE CONNECTOR MAY RESULT IN THE DEVICE MALFUNCTIONING OR IN INACCURATE PRESSURE READINGS. IF THIS OCCURS, REPLACE WET PART OR PARTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USING OF A EDWARDS ARTERIAL LINE TUBING AND TRANSDUCER, THE READING WAS 40 POINTS ABOVE THE NON-INVASIVE BLOOD PRESSURE CUFF. NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458882 TRUWAVE, VAMP PLUS TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR DPTUNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown