BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR SOLUTIONS WARMER DRAPE

    MDR report key: 2232273 · Received August 15, 2011

    Report

    Report Number
    MW5021935
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 11, 2011
    Manufacturer
    OR SOLUTIONS
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FROM SURGERY THAT AFTER A PROCEDURE IT WAS NOTICED THAT THERE WAS A TEAR IN THE LINER FOR THE ORS WARMER. NOT SURE WHEN THE TEAR OCCURRED BUT THIS HAS THE POTENTIAL OF CAUSING CONTAMINATED FLUIDS TO BE USED DURING A CASE. NO SHARP OBJECTS WERE PLACED IN THE LINER EXCEPT A BLUNT NEEDLE AND SYRINGE TO DRAW UP FLUID. THE CONCERN IS THAT THERE COULD BE MORE OCCURRENCES OF CONTAMINATED FLUID USED DURING A CASE WHEN THE TEARS ARE NOT DETECTABLE UNTIL AFTER A CASE IS FINISHED AND THE ROOM IS BEING BROKEN DOWN. AFTER FURTHER EVAL WE ARE REPORTING THIS TO MEDWATCH SYSTEM AS A PT SAFETY CONCERN. OUR OPERATING ROOM DIRECTOR IS GOING TO BE CONTACTING THE COMPANY TO SEE WHETHER MORE DURABLE LINERS ARE AVAILABLE. THE PT IN THIS PARTICULAR CASE DID RECEIVE ANTIBIOTICS PROPHYLACTICALLY PRIOR TO THE CASE AND HAS HAD NO SUBSEQUENTLY ADMISSIONS. THE LINER USED IN THIS CASE HAS BEN SEQUESTERED TO PT SAFETY/RISK MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OR SOLUTIONS WARMER DRAPE FLUID WARMER DRAPE KKX OR SOLUTIONS 0111005

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR