BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B105 MULTI POSITION BLANKET

    MDR report key: 21213454 · Received January 22, 2025

    Report

    Report Number
    3005857264-2025-00002
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 11, 2023
    Report Date
    January 22, 2025
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT
    Product Code
    DWJ
    UDI-DI
    00855913001381
    PMA / PMN Number
    K052392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT MISUSE, RESULTING IN A PRODUCT MALFUNCTION, WAS THE ROOT CAUSE OF THE REPORTED PATIENT INJURY. THE PRODUCT WAS MISUSED IN TWO SEPARATE WARNED-AGAINST WAYS: EXPIRED PRODUCT, AND WE SUSPECT RESETTING ALARMS. THE BLANKET WAS EXPIRED WHEN THE PATIENT INJURY OCCURRED. THE IFU WARNS "DO NOT CONTINUE TO USE HOT DOG WARMING BLANKETS BEYOND THE LABELED EXPIRATION DATE, FOUND ON THE CABLE." THIS BLANKET WAS MANUFACTURED IN JANUARY 2020 AND SHOULD HAVE BEEN REPLACED IN SEPTEMBER 2022. BLANKETS MANUFACTURED AFTER JUNE 2022 ARE NOT SUSCEPTIBLE TO THIS HAZARD AS THE BUSBAR AREA IS THERMALLY INSULATED, EVEN IF ONE WERE TO OCCUR.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE REPORTER INITIALLY IN AN EMAIL "WHEN REMOVING (KC-T1) B105 [HOTDOG BLANKET B105] FROM THE PATIENT AFTER THE SURGERY, REDNESS INCLUDING PARTIAL BLISTERS WERE OBSERVED FROM THE HIGH PART OF THE PATIENT'S CHEST TO THE UPPER SIDE OF HER TORSO". LATER ON, ON (B)(6) 2024, WE GOT ADDITIONAL DETAILS IN A FILLED-OUT INCIDENT REPORT: "PROCEDURE: ARTIFICIAL JOINT REPLACEMENT WAS PERFORMED FOR THE PATIENT'S LEFT OSTEOARTHRITIS OF THE KNEE. BEFORE THE OPERATION, A DOUBLE LAYER OF A BATH TOWEL WERE PLACED ON BOTH UPPER LIMBS AND ANTERIOR CHEST, AND A PAD OF THE DRESSING (THE HOTDOG [WARMING BLANKET B105]) WAS PLACED ON IT AND SET AT 38C (10 A.M.) WHEN REMOVING THE HOTDOG AFTER THE SURGERY (12 NOON), IT WAS CONFIRMED THAT THE TEMPERATURE WAS MODERATE. AFTER EXTUBATION, PATIENT'S SKIN WAS OBSERVED AND TWO BLISTER FORMATIONS WERE CONFIRMED IN THE RIGHT ARMPIT AND ON ANTERIOR CHEST AS WELL AS REDNESS OF 15X10CM SIZE IN THE RIGHT ANTERIOR CHEST AREA." ON (B)(6) 2024, THE REPORTER SENT A CORRECTION TO THE INCIDENT REPORT, THEY MARKED THE INJURY IS OF A 3RD DEGREE, WITH A SIZE OF LESS THAN 1 SQ INCH (6.5 SQ CM). PER AUGUSTINE'S INVESTIGATION: THE HOTDOG PATIENT WARMING BLANKET B105 WAS EVALUATED/INVESTIGATED BY AUGUSTINE TEMPERATURE MANAGEMENT (ATM) AND WAS OBSERVED TO HAVE MALFUNCTIONED DURING USE. WHEN TESTED, THE B105 FAILED THE FUNCTIONAL TEST REQUIREMENTS AND ALSO DID TRIGGER AN E2 ALARM. UPON INVESTIGATION, FAILURE WAS OBSERVED ON THE NEGATIVE BUSBAR AT THE CONDUCTIVE THREAD/CONDUCTIVE FABRIC CONTACT POINTS. THE RESULTING HOTSPOTS CAUSED THE REPORTED PATIENT INJURY. THE FAILURE APPEARED TO START AT THE CENTER OF THE NEGATIVE BUSS BAR (ON THE DEPENDENT PANEL) AND PROPAGATED OUTWARDS. ENGINEERING CONCLUDES THAT THE MAIN CONTRIBUTING FACTOR(S) TO THIS FAILURE WAS CAUSED BY THE BLANKET BEING SIGNIFICANTLY PAST ITS EXPECTED LIFE OF 30 MONTHS. THE BLANKET WAS 46.5 MONTHS OLD AND EXPIRED AT THE TIME OF THE ADVERSE EVENT AND IT SHOULD HAVE BEEN REPLACED BY THE END USER. THE RESULTING HOTSPOT IN A BUSBAR FAILURE IS ABOUT 2MM WIDE AT THE EDGE OF THE BLANKET. THIS CORRESPONDS WITH THE REPORTED SMALL (<1 SQ IN) 3RD DEGREE BURN BASED ON HOW THE BLANKET WAS POSITIONED ON THE PATIENT AND THE LOCATION OF THE FAILURE. ATM HAS LEARNED THAT THE HOSPITAL AND MARKET AUTHORIZATION HOLDER HAVE FILED OFFICIAL REPORTS WITH JAPAN'S PMDA (PHARMACEUTICAL AND MEDICAL DEVICES AGENCY). HOTDOG PATIENT WARMING BLANKET IFU P/N 1718 S AND PRODUCT LABELING ON THE BLANKET SHELLS WARN TO NOT USE HOTDOG BLANKETS PAST THEIR LABELED EXPIRY. THE B105, SN (B)(6) HAD A 30 MONTH EXPIRY, BUT WAS USED FOR 46.5 MONTHS BEFORE CAUSING THE INCIDENT. PRODUCT MISUSE, RESULTING IN A PRODUCT MALFUNCTION, WAS THE ROOT CAUSE OF THE ADVERSE EVENT. BLANKETS MANUFACTURED AFTER JUNE 2022 ARE NOT SUSCEPTIBLE TO THIS FAILURE MODE AND THE BUSBAR AREA IS THERMALLY INSULATED EVEN IF ONE WERE TO OCCUR. SEE SECTION H11 FOR ADDITIONAL MANUFACTURER NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791953 B105 MULTI POSITION BLANKET MULTI POSITION BLANKET DWJ AUGUSTINE TEMPERATURE MANAGEMENT B105 00855913001381

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other