BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION WANT

    MDR report key: 2951133 · Received February 8, 2013

    Report

    Report Number
    3008500478-2013-00381
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DTS
    PMA / PMN Number
    K831759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY UNDER INVESTIGATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    EVALUATION: IT WAS CONFIRMED THE TIP OF THE SUCTION WAND WAS BROKEN OFF. THE BREAK WAS IN THE TIP ITSELF. ALL 4 DETENTS FROM THE STAKING PROCESS WERE PRESENT AND PART OF THE TIP WAS STILL INSIDE OF THE DEVICE. THE TIP ITSELF BROKE IN HALF. NO OTHER PROBLEMS WERE FOUND WITH THE DEVICE. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE DID HAVE THE FOUR STAKING DETENTS IN IT SO IT IS CLEAR THAT THE DEVICE DID GO THROUGH THE STAKING PROCESS. THE TIP BREAK WAS A MATERIAL FAILURE, BUT A REVIEW OF THE MATERIAL LOT REVEALED NO NONCONFORMANCES RELATED TO THIS LOT OF MATERIAL. OTHER POSSIBLE CAUSES THAT COULD HAVE CONTRIBUTED BUT COULD NOT BE INVESTIGATED INCLUDE, SHIPPING DAMAGE, USER ERROR, AND STORAGE CONDITIONS. THE COMPLAINT TREND IS WITHIN THE EXPECTED LIMITS, AND A MANUFACTURING DEFECT COULD NOT BE CONFIRMED, THUS NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A REVIEW OF MANUFACTURING RECORDS SHOWED NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUCTION "CANNULA TIP GOT BROKEN OFF AT THE CONNECTION TO THE CANNULA BODY DURING USE." PER THE HOSPITAL, STRONG FORCE WAS NOT APPLIED TO THE DEVICE." THE CUSTOMER COMMENTED THAT THE FRAGMENT OF THE CANNULA TIP DID NOT REMAIN INSIDE THE PATIENT BODY. THERE ARE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54639 SUCTION WANT SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS DTS EDWARDS LIFESCIENCES SPC2081 59311634

    Patients

    Seq Age Sex Outcome Treatment
    1