BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE VAMP PLUS

    MDR report key: 21809881 · Received April 9, 2025

    Report

    Report Number
    2015691-2025-02761
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Report Date
    September 17, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    PMA / PMN Number
    K141495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED DURING USE IN A PATIENT THE PRESSURE TUBING ON THE PLANECTA LOCATED CLOSER TO THE DISTAL END OF THIS PRESSURE MONITORING SET GOT DETACHED FROM THE CONNECTOR. INFORMATION REGARDING THE EXACT TIMING OF THE DETACHMENT OR WHETHER THE DEVICE WAS REPLACED WAS UNABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF BLOOD LEAKAGE OR PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION. 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 INVESTIGATION IS COMPLETED. THE DEVICE HISTORY REVIEW WAS NOT COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. 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 FDA PRODUCT CODES INCLUDE: DXO - TRANSDUCER, PRESSURE, CATHETER TIP.

    Additional Manufacturer Narrative · 0

    ONE PRESSURE MONITORING SET WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF TUBING GOT DETACHED WAS CONFIRMED. AS RECEIVED, PRESSURE TUBING WAS COMPLETELY DETACHED FROM BONDED JOINT CONNECTION WITH DISTAL PLANECTA. INDICATION OF BONDING MATERIAL WAS EVIDENT ON TUBING BOND SURFACE AREA. NO OTHER VISIBLE DAMAGE OR INCONSISTENCY WAS OBSERVED FROM RETURNED KIT. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE LOT NUMBER WAS NOT REPORTED. DURING THE EXECUTION OF THE ENGINEERING EVALUATION PROCESS, IT WAS IDENTIFIED THAT THE INVOLVED DEVICE IS MANUFACTURED BY THE "JMS" THIRD PARTY MANUFACTURER, AND THESE DEVICES ARE NOT PROCESSED INTERNALLY IN THE BD APM MANUFACTURING PROCESS. JMS PERFORMS THE FOLLOWING MANUFACTURING CONTROLS: SAMPLING INCOMING INSPECTION, VISUAL INSPECTION, DIMENSIONAL MEASUREMENT, AND LEAK TEST. IT WAS CONFIRMED THAT TUBE WAS DETACHED FROM DISTAL PLANECTA. BOND INDICATION WAS OBSERVED ON DETACHED TUBE, AND IT WAS CONSIDERED THAT THE TUBE HAD BEEN INSERTED PROPERLY. MANUFACTURING PROCESS WAS INVESTIGATED, BUT NO ABNORMALITY WAS OBSERVED. IT WAS SUSPECTED THAT BENT FORCE AND/OR TENSILE FORCE, WHICH WERE EXCEEDED BOND STRENGTH, WERE APPLIED TO THE TUBING, AND THEN BOND JOINT COME OFF AND TUBING WAS DETACHED. HOWEVER, ROOT CAUSE COULD NOT BE DETERMINED DURING THIS INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED DURING USE IN A PATIENT THE PRESSURE TUBING ON THE PLANECTA LOCATED CLOSER TO THE DISTAL END OF THIS PRESSURE MONITORING SET GOT DETACHED FROM THE CONNECTOR. INFORMATION REGARDING THE EXACT TIMING OF THE DETACHMENT OR WHETHER THE DEVICE WAS REPLACED WAS UNABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF BLOOD LEAKAGE OR PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816264 TRUWAVE VAMP PLUS PRESSURE MONITORING SET KRA EDWARDS LIFESCIENCES DR PXVPP11127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown