BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOFLECT

    MDR report key: 1566174 · Received December 22, 2009

    Report

    Report Number
    1641118-2009-00001
    Event Type
    Injury
    Date Received
    December 22, 2009
    Date of Event
    November 22, 2009
    Report Date
    December 22, 2009
    Manufacturer
    INDUSTRIA MANUFACTUREAS DE TAMAULIPAS, SA DE C.V.
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN PACU AFTER RECEIVING AN MRI. UPON ARRIVAL IN PACU, A 3RD DEGREE BURN ON THE PT'S ELBOW WAS DISCOVERED. THE HOSPITAL STAFF WAS NOT AWARE OF HOW THE BURN OCCURRED, AND SUBSEQUENTLY STARTED AN INVESTIGATION. THE INVESTIGATION PRIMARILY FOCUSED ON THE MRI AND ANY PRODUCTS IN CONTACT WITH THE PT DURING THE MRI, INCLUDING A THERMOFLECT BLANKET, A WARMED BLANKET, AND AN IV ENTRY POINT NEAR THE BURN WOUND. THE PT ARRIVED FOR THE MRI WITH THE THERMOFLECT BLANKET HAVING BEEN APPLIED BY THE ANESTHESIOLOGIST. THERMOFLECT BLANKETS WERE NOT PART OF THE MRI PROTOCOL AND HAD NOT BEEN USED BEFORE. THE PT WAS COMPLETELY WRAPPED ("COCOONED") IN THE THERMOFLECT BLANKET DURING THE MRI PROCEDURE. ADDITIONALLY, A WARMED BLANKET WAS PLACED OVER THE PT AND THE STANDARD VELCRO PT RESTRAINTS WERE IN PLACE. THE MRI STAFF DID NOT WITNESS THE BURN EVENT AND WAS UNAWARE OF THE BURN UNTIL THE PT WAS DELIVERED TO PACU. AFTER THE INVESTIGATION, THE DIRECTOR OF PEDIATRIC RADIOLOGY HYPOTHESIZED THAT THE POSITIONING OF THE THERMOFLECT BLANKET WRAPPED AROUND THE BABY CREATED A "LOOPING" OR "COILING" OF THE ALUMINUM LAYER CONTAINED WITHIN THERMOFLECT; AND WHEN SUBJECT TO THE MRI, A CURRENT FORMED THAT ARCED AND BURNED THE PT'S ELBOW. THE DIRECTOR REFERENCED FARADAY'S LAW OF INDUCTION AS THE BASIS FOR HIS HYPOTHESIS. THE DIRECTOR DID TEST THERMOFLECT LYING FLAT FOR RESISTANCE TO TRANSVERSE CURRENT, AND IT PROVED TO BE VERY RESISTANT - I.E. NON-CONDUCTIVE. HOWEVER, HIS HYPOTHESIS INFERRED THAT THE POSITIONING OF THE BLANKET ALLOWED A CURRENT TO DEVELOP BASED ON FARADAY'S LAW. THE DIRECTOR DID NOT TEST THERMOFLECT IN A "LOOPED" POSITION AND DID NOT RECREATE THE CURRENT AND ARC THAT HE HYPOTHESIZED. HE CITED SAFETY CONCERNS FOR NOT PERFORMING THIS TEST. AS PART OF OUR INVESTIGATION, WE ARE CONTACTING TESTING FACILITIES TO TEST THE DIRECTOR'S HYPOTHESIS. WE WILL SUBMIT FOLLOW-UP REPORTS AS MORE INFORMATION BECOMES AVAILABLE. ACCORDING TO THE DIRECTOR, THE PT'S BURN REQUIRED STITCHES AND THE WOUND IS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOFLECT FME KME INDUSTRIA MANUFACTUREAS DE TAMAULIPAS, SA DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Required Intervention IV PORT| VELCRO RESTRAINTS| GE SIGNA MRI MACHINE 1.5T| WARM BLANKET| THERMADRAPE BLANKET