BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP

    MDR report key: 24482504 · Received March 2, 2026

    Report

    Report Number
    2015691-2026-11648
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 7, 2026
    Report Date
    May 13, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    07460691955073
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE VAMP ADULT SYSTEM WAS RETURNED FOR EVALUATION. DRY BLOOD WAS VISIBLE THROUGHOUT THE SYSTEM. THE CUSTOMER REPORT OF TUBING DETACHED AT THE VAMP WAS CONFIRMED. AS RECEIVED, THE PRESSURE TUBING WAS COMPLETELY DETACHED FROM BOND JOINT WITH VAMP RESERVOIR STOPCOCK. INDICATION OF BONDING MATERIAL WAS EVIDENT ON TUBING BOND SURFACE AREA. TUBING OUTER DIAMETER WAS WITHIN SPECIFICATION. NO OTHER VISIBLE DAMAGE OR DEFECT WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE EVIDENCE, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE CONFIRMED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS UNDERGO A PULL TEST, FLOW TEST, AND VISUAL INSPECTION. THE INSTRUCTIONS FOR USE ALSO INCLUDE CLEAR INSTRUCTIONS ON HOW TO PROPERLY SET UP THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DXO- TRANSDUCER, PRESSURE, CATHETER TIP. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT BEEN COMPLETED. 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 DURING USE OF THE TRUWAVE THE PATIENT'S ARTERIAL LINE TUBING SNAPPED AND DISCONNECTED AT THE CONNECTION OF THE DISTAL TUBING & THE VAMP, LEADING TO THE PATIENT BLEEDING. THE TRANSDUCER ALARM FROM THE MONITOR WENT OFF, TELLING THE CUSTOMER THAT THERE WAS AN ARTERIAL LINE DISCONNECTION SO THAT THEY COULD QUICKLY INTERVENE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125458 TRUWAVE, VAMP CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXVMP120 NI 07460691955073

    Patients

    Seq Age Sex Outcome Treatment
    1