BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMFLO INFUSION WARMER

    MDR report key: 2517615 · Received March 30, 2012

    Report

    Report Number
    2936999-2012-00115
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 29, 2012
    Manufacturer
    COVIDIEN / FORMERLY TYCO
    Product Code
    LHC
    PMA / PMN Number
    BK950021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE RECORDS FOR THIS SERIAL NUMBER (B)(4) (UNIT) WAS REVIEWED AND CONFIRMS THAT IT WAS MANUFACTURED NOVEMBER 2004 HAVING PASSED ALL PERFORMANCE INSPECTION/TESTING. THE UNIT HAS BEEN OWNED BY THE SAME CUSTOMER SINCE (B)(6) 2005 AND THERE IS NO HISTORY OF THE UNIT BEING RETURNED FOR ANY SERVICE/REPAIRS PERFORMED. THE FW588 INFUSION WARMER IS NOT DISTRIBUTED IN THE U.S., HOWEVER, THE FW538 IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE FW538 IS BK950021. THE WARMFLO UNIT SERIAL NUMBER (B)(4) WAS RECEIVED BY THE MFR'S SERVICE DEPARTMENT IN A CONTAMINATED CONDITION THAT MAY POTENTIALLY BE HAZARDOUS. TECHNICIANS ARE ONLY ABLE TO EVALUATE THE UNIT IN A MANNER SAFE FOR HANDLING. THE UNIT WAS PLUGGED IN BY THE ENGINEER USING THE ENCLOSED POWER CORD RETURNED BY THE CUSTOMER. THE UNIT IS TOTALLY DEAD (NO POWER) THEREFORE OTHER FUNCTIONAL TESTS CANNOT BE PERFORMED. THE UNIT WAS ALSO TESTED USING A SERVICE DEPARTMENT RETAINED POWER CORD AND THE UNIT STILL WOULD NOT POWER ON. THE RIGHT SIDE CASING OF THE UNIT WAS OBSERVED TO BE DAMAGED; CRACKED AND A PIECE MISSING. THE USED CASSETTE WAS NOT RETURNED WITH THE UNIT TO EXAMINE FOR POSSIBLE LEAKS OR OTHER DAMAGE/FAILURE THAT COULD BE RELATED TO THE UNIT'S PERFORMANCE. AT THIS TIME, THE BRAND OF CASSETTE BEING USED COULD NOT BE CONFIRMED. IT IS UNK AT THIS TIME IF THE CASSETTE BEING USED WAS PRIMED (PRE-WARMED) OR WHAT SETTINGS WERE ON THE UNIT BEFORE AND DURING USE. IT IS UNK IF THE UNIT WAS FUNCTIONALLY TESTED PRIOR TO USE. AS THE UNIT IS NON-FUNCTIONING A FAILURE MODE AND ROOT CAUSE CANNOT BE DETERMINED. IF FURTHER ANALYSIS CAN BE PERFORMED, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    HOSPITAL REPORTED, A CHILD WAS RECEIVING A BLOOD TRANSFUSION VIA A WARMER .37MLS SHORT OF COMPLETION THE MACHINE MALFUNCTIONED AND THE GIVING SET SPECIFIC TO THE MACHINE RUPTURED CAUSING THE BLOOD TO SPILL OUT OF THE MACHINE ONTO THE FLOOR. DUE TO THE AMOUNT OF BLOOD WE WERE UNABLE TO TELL WHETHER THE MACHINE CAUSED THE BAG TO RUPTURE OR NOT. THE DOCTOR INFORMED THAT THE PT HAD RECEIVED LESS OF HER TRANSFUSION THAN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMFLO INFUSION WARMER INFUSION WARMER LHC COVIDIEN / FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention