BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOWER MISTER, 5-PACK

    MDR report key: 21351446 · Received February 10, 2025

    Report

    Report Number
    2242352-2025-0000123
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 14, 2025
    Report Date
    April 3, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    FQK
    UDI-DI
    00607567700741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED SECTIONS: B4,G3,G6,H2,H3,H6,H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 01/21/2025. AN INVESTIGATION WAS CONDUCTED ON 2/25/2025. AN VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT DEVICE. THE FLOW VOLUME CONTROLLER WAS INSPECTED AND WAS OBSERVED TO HAVE NO VISUAL OR PHYSICAL DEFECTS. THE CONTROLLER WAS ABLE TO BE ROLLED WITH NO PHYSICAL DIFFICULTIES. THE SPIKE CHAMBER WAS RETURNED FILLED WITH SALINE. A FUNCTIONAL TEST WAS PERFORMED. REFERENCE BRAIDED TUBING WAS CONNECTED TO A REGULATED SOURCE OF CO2, NOT EXCEEDING 50 PSI (344 KPA). THE FLOW WAS ADJUSTED TO 5 L/MIN (0.08 L/S). CO2 GAS WAS ABLE TO FLOW THROUGH THE IV TUBING AND WAS VISIBLY AND AUDIBLY OBSERVED COMING OUT OF THE ATRAUMATIC TIP . THE IV SPIKE WAS CONNECTED TO A BAG OF SALINE THROUGH THE IV LUER LOCK CONNECTION. THE BAG WAS PLACED IN A PRESSURE CUFF AND INFLATED TO APPROXIMATELY 150 MMHG (20KPA). THE PINCH CLAMP WAS OPENED AND SALINE FLOW WAS ADJUSTED TO 1¿5 (ML/MIN) USING THE ROLLER CLAMP ON THE IV TUBING. SALINE WAS OBSERVED TO COME OUT OF THE ATRAUMATIC TIP WITH NORMAL FLOW AND NO BLOCKAGES. THE IRRIGATION MIST WAS OBSERVED TO FLOW OUT OF THE TIP AS EXPECTED. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "IMPROPER FLOW OR INFUSION" WAS NOT CONFIRMED. THE LOT # 96255755 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING BLOWER MISTER, WHEN THE CO2 BLOWER WAS USED ON THE ANASTOMOSIS SITE TO REMOVE BLOOD AND SECURE A FIELD OF VISION, THE BLOOD WAS NOT REMOVED AND THE CO2 WAS NOT DISCHARGED. IT WAS DETERMINED THAT THIS PRODUCT WAS DEFECTIVE AND A NEW PRODUCT WAS USED TO PERFORM THE SURGERY. THE NEWLY USED CO2 BLOWER PRODUCT HAD NO PROBLEMS WITH REMOVING BLOOD OR SECURING A FIELD OF VISION DURING THE ANASTOMOSIS, SO THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER CONFIRMING THE DEFECT IN THE PRODUCT, A NEW PRODUCT WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PROCEDURE DELAYED BY ABOUT 20-30 MINUTES

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836523 BLOWER MISTER, 5-PACK BINDER, PERINEAL FQK MAQUET CARDIOVASCULAR LLC CB-1000 96255755 00607567700741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.