BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSWARMER

    MDR report key: 13723905 · Received March 10, 2022

    Report

    Report Number
    1216677-2022-00061
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    January 21, 2022
    Report Date
    November 17, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    PMA / PMN Number
    K934631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION UPDATE: COOPERSURGICAL'S INITIAL FOLLOW-UP ATTEMPTS TO OBTAIN THE DEVICE WERE NOT RESPONDED TO, BUT UPON FURTHER FOLLOW-UP WE WERE ABLE TO ACQUIRE THE DEVICE ON 10/11/2022 AND HAVE CONDUCTED AN EVALUATION. A SUMMARY OF THE EVALUATION IS AS FOLLOWS: THE RETURNED TRANSWARMER WAS BOILED TO BRING IT BACK TO A USABLE STATE. THE DEVICE WAS THEN LEFT TO COOL TO 76 DEGREES F AND ACTIVATED. THE ACTIVATION TEMPERATURE WAS 126 DEGREES F, WHICH IS OUTSIDE THE SPECIFIED RANGE OF 102 DEGREES F TO 105 DEGREES F. THE DEVICE IS REV.004, WHICH INDICATES THE LATEST POSSIBLE PRODUCTION DATE IS JUNE 2013, SO IT IS AT LEAST 9 YEARS OLD. OVER TIME WATER WILL EVAPORATE OUT OF THE SOLUTION RAISING THE RATIO OF SODIUM TO WATER, THE HIGHER THE RATIO OF SODIUM THE HIGHER THE ACTIVATION TEMPERATURE. THE SHELF LIFE FOR TRANSWARMER IS 2.5 YEARS AND MARKED ON ALL DEVICES AS OF AUGUST 2013.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLE RETURNED. *ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM PRISTECH PRODUCTS INC. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED BECAUSE THE COMPLAINT PRODUCT LOT/SERIAL NUMBER WAS NOT PROVIDED. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE INCOMING INSPECTION REPORT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    PER MEDWATCH. INFANT BACK & BUTTOCKS' WAS BURN RED AFTER TRANSWARMER WAS USED LESS THAN 10 MINUTES. WOUND CARE TEAM CONSULTED AND INTERVETION INITIATED. TRANSWARMER INF BOX OF (6) 20421, E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    PER MEDWATCH. INFANT BACK & BUTTOCKS' WAS BURN RED AFTER TRANSWARMER WAS USED LESS THAN 10MINUTES. WOUND CARE TEAM CONSULTED AND INTERVETION INITIATED. 1216677-2022-00061-2 TRANSWARMER INF BOX OF 6 20421 (B)(4).

    Description of Event or Problem · 0

    PER MEDWATCH- INFANT BACK & BUTTOCKS' WAS BURN RED AFTER TRANSWARMER WAS USED LESS THAN 10MINUTES. WOUND CARE TEAM CONSULTED AND INTERVETION INITIATED. 1216677-2022-00061-1 TRANSWARMER INF BOX OF 6 20421 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116610 TRANSWARMER TRANSWARMER IMD COOPERSURGICAL, INC. 20421 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other