BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FAST FLOW - TRAUMA FLUID WARMER

    MDR report key: 18751518 · Received February 21, 2024

    Report

    Report Number
    2183161-2024-00156
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 19, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSB
    UDI-DI
    50695085829506
    PMA / PMN Number
    BK020043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THE FILE IT WAS DETERMINED THAT IS WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN 2183161-2024-00156. PLEASE REFERENCE FILE MDN 2183161-2024-00149 FOR ALL DETAILS PERTINENT TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. D5. OTHER OPERATOR OF DEVICE: OPERATOR OF DEVICE IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTIONS: D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MFG DATE: 15-JUL-2017. INVESTIGATION SUMMARY: THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A BIG CHUNK BROKEN OFF OF THE ENCLOSURE ON THE SIDE OPPOSITE THE AIR DETECTOR AND ALONG THE BACK EDGE. THERE WAS A BACK PANEL SCREW BROKEN OFF IN ONE OF THE ENCLOSURE INSERTS. THE RETURN TUBE WAS CRACKED, ALLOWING AIR INTO THE SYSTEM AND CAUSING THE DEVICE TO FAIL THE FLOW RATE TEST, BELOW 1 GPM. THE FLOAT SWITCH STUCK TO THE PLASTIC RETAINING RING, CAUSING THE WATER LEVEL ALARM TO SOUND AND THE DEVICE NOT TO ENTER "OPERATION MODE". THERE WAS EVIDENCE OF FLUID INGRESSION ON THE PCB FROM THE CRACKED RETURN TUBE. THE BOTTOM SOCKET THERMISTOR HAD ABNORMALLY LONG WIRES, AND AFTER INVESTIGATING FURTHER IT WAS NOTICED THAT IT WAS MISSING A FERRITE BEAD, WHICH WOULD SHORTEN THE WIRE LENGTH APPROPRIATELY BECAUSE IT GETS LOOPED THROUGH THE BEAD A SECOND TIME BEFORE BEING SECURED WITH A HEAT SHRINK. AFTER PCB REPLACEMENT, THE HEATER RELAYS ON THE PCB WERE BEING TRIPPED DUE TO FAULTY HEATER/S. THE DRAIN VALVE WAS CORRODED WHERE IT COULD NOT BE OPENED BY HAND. HEATER #1 WAS FOUND TO HAVE RIPS IN THE HEATER TAPE. THE AUX. OUTLET GROUND WIRE CONNECTION WAS BROKEN. THE DEVICE WAS FILLED WITH FLUID, A TEMP CHECK AND F-30 GAS/VENT TEST FILTER WERE INSTALLED, AND FUNCTIONAL TESTING WAS PERFORMED. UPON STARTING THE FLOAT SWITCH MALFUNCTIONED AND CAUSED THE WATER LEVEL ALARM TO ACTIVATE. THE HEATER RELAYS ON THE PCB WERE BEING TRIGGERED EVERY SO OFTEN, RELATING TO THE INTERNAL SENSOR FAILING. THE CUSTOMER'S INDICATED FAILURE WAS CONFIRMED. THE ROOT CAUSE WAS FOUND TO BE A CHUNK OF GREASE STUCK TO THE PLASTIC RETAINING RING HOLDING THE FLOAT SWITCH ON, CAUSING THE FLOAT TO STICK IN PLACE AND ACTIVATING THE ALARM. A FAULTY HEATER CAUSED THE RELAYS TO TRIP ON THE PCB. AS A RESULT, THE FLOAT SWITCH WAS REMOVED AND THOROUGHLY CLEANED. BOTH OF THE OLD DESIGN HEATERS WERE REPLACED, AS WELL AS ADDING THE MISSING FERRITE BEAD/HEAT SHRINK TO THE BOTTOM OF THE SOCKET THERMISTOR. THE PCB, BOTH HEATERS, DRAIN VALVE, AUX. OUTLET, RETURN TUBE, O-RINGS, AND FAN GUARD WERE REPLACED ALSO. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSORS FAILED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642362 LEVEL 1 FAST FLOW - TRAUMA FLUID WARMER WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB SMITHS MEDICAL ASD, INC. 50695085829506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown