BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 FAST FLOW FLUID WARMER

    MDR report key: 15250220 · Received August 18, 2022

    Report

    Report Number
    3012307300-2022-15597
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Report Date
    April 28, 2023
    Manufacturer
    ST PAUL
    Product Code
    BSB
    UDI-DI
    50695085829506
    PMA / PMN Number
    BK020043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    OTHER TEXT: NO PATIENT INVOLVEMENT. (UPDATED B5). 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

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO A PREVIOUS REPAIR. VISUAL INSPECTION OF THE DEVICE FOUND IT WITH CRACKED RETURN TUBE, FLUID INGRESSION ON THE PRINTED CIRCUIT BOARD (PCB) AND A BURNT MEMBRANE SWITCH. THERE WAS NO EVIDENCE OF THE REPORTED ERROR IN THE EVENT HISTORY LOG (EHL). THE REPORTED PROBLEM WAS VERIFIED/DUPLICATED; THE RETURN TUBE CRACKED, WHICH CAUSED THE WATER LEAK ONTO PCB. FOR CORRECTIVE ACTION, THE RETURN TUBE WAS REPLACED. THE ROOT CAUSE WAS TRACED TO DESIGN AND MANUFACTURING, WHICH WAS ADDRESSED THROUGH CAPA-000399. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE DEVICE IS BEYOND A YEAR FROM ITS MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY. AN INTERNAL SCAR HAS BEEN OPENED AND THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THERMOMETER DISPLAY WOULD NOT ADJUST TO MATCH TEST EQUIPMENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFO RECEIVED VIA EMAIL 20-AUG-2022. EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038267 LEVEL 1 FAST FLOW FLUID WARMER WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB ST PAUL 8002950 50695085829506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown