BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE WAVE VAMP

    MDR report key: 21595050 · Received March 13, 2025

    Report

    Report Number
    2015691-2025-01854
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Report Date
    August 11, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRA
    UDI-DI
    00690103011494
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT YET ARRIVED. ONCE IT HAS ARRIVED AND THE PRODUCT EVALUATION COMPLETED THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE DEVICE HISTORY RECORD REVIEW IS PENDING, ONCE THE RESULTS ARE AVAILABLE, THEY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ADDITIONAL PRODUCT CODE DXO.

    Additional Manufacturer Narrative · 0

    THERE IS NO PRODUCT EVALUATION RESULTS AS THE DEVICE WAS DISCARDED AND NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. 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 PART OF THIS MONTHLY REVIEW. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES.

    Additional Manufacturer Narrative · 0

    ONE DPT VAMP ADULT KIT WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE THAT THE TUBING BECAME DISCONNECTED WAS CONFIRMED. AS RECEIVED THE PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM THE VAMP RESERVOIR BOND JOINT. THERE WAS ADHESIVE TAPE BETWEEN DETACHED TUBING AND THE RESERVOIR. INDICATIONS OF WHAT APPEARED TO BE BONDING MATERIAL WERE EVIDENT ON THE TUBING BOND SURFACE AREA. THE TUBING OUTER DIAMETER WAS MEASURED TO BE 0.1415 NEAR THE POINT OF DETACHMENT. THERE WAS NO OTHER VISIBLE DAMAGE OR INCONSISTENCY FOUND WITH THE RETURNED KIT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT OR USER ERROR. NO SPECIFIC ROOT CAUSE COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A FAILURE WITH A PRESSURE MONITORING KIT. THE TUBING ON THE DEVICE BROKE AND BECAME DISCONNECTED ON THE PATIENT SIDE OF THE FLOW RESTRICTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495199 TRUE WAVE VAMP PRESSURE MONITORING KIT KRA EDWARDS LIFESCIENCES PXAVMP 65909306 00690103011494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown