BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM

    MDR report key: 13514075 · Received February 11, 2022

    Report

    Report Number
    2015691-2022-03900
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    December 29, 2021
    Report Date
    February 11, 2022
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    PMA / PMN Number
    K173586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, THE RELATED MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED. WITHOUT RETURN OF THE PRODUCT, EDWARDS IS UNABLE TO PERFORM A COMPLETE INVESTIGATION OF THE REPORTED EVENT. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED. SINCE THE AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, THE RELATED MANUFACTURING RECORDS WERE UNABLE TO BE REVIEWED. WITHOUT RETURN OF THE PRODUCT, EDWARDS IS UNABLE TO PERFORM A COMPLETE INVESTIGATION OF THE REPORTED EVENT. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED. SINCE THE AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING USE IN PATIENT WITH THIS PRESSURE MONITORING SET WITH VAMP JR, A LOT OF AIR WAS ASPIRATED INTO THE VAMP RESERVOIR WHEN BLOOD WAS DRAWN. THE VAMP JR SET WAS DISCONNECTED AND REMOVED. THE ISSUE WAS SOLVED BY REPLACING THE DEVICE WITH A NEW SET. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

    Description of Event or Problem · 0

    AS REPORTED, DURING USE IN PATIENT WITH THIS PRESSURE MONITORING SET WITH VAMP JR, A LOT OF AIR WAS ASPIRATED INTO THE VAMP RESERVOIR WHEN BLOOD WAS DRAWN. THE VAMP JR SET WAS DISCONNECTED AND REMOVED. THE ISSUE WAS SOLVED BY REPLACING THE DEVICE WITH A NEW SET. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182259 VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR T470411B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown