BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 13122276 · Received December 30, 2021

    Report

    Report Number
    3012307300-2021-13526
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    November 10, 2021
    Report Date
    May 12, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPB
    UDI-DI
    10351688510983
    PMA / PMN Number
    K860803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. WATER LEAK TEST: RETURNED SAMPLE WAS TESTED AT 20PSI FOR WATER LEAK. THE SAMPLE EXHIBITED LEAKAGE CONDITION AT THE FILTER. VISUAL INSPECTION: THE BONDING OF TUBE WITH FILTER WAS INSPECTED. THE LACK OF SOLVENT WAS OBSERVED ON THE BONDING OF TUBE WITH FILTER. LEAKAGE AT FILTER DEFECT. THE COMPLAINT ISSUE WAS CONFIRMED. ACTIONS TAKEN: SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED TO INDUSTRIE BORLA SUPPLIER. ADDITIONALLY, LOT 8925/21 AVAILABLE AT WAREHOUSE OF FILTER PN: P1123-07 WAS INSPECTED ACCORDING TO INSPECTION PROCEDURE FOR FILTER, TO CORROBORATE IF PIECES DID NOT EXHIBIT LEAKAGE CONDITION AS THE SAMPLE RETURNED FROM CUSTOMER. RESULTS: NO DEFECTS WERE OBSERVED ON A SAMPLING OF 80 PIECES PER LOT FOR LEAKAGE TEST. LEAKAGE AT BONDING OF TUBE WITH FILTER WAS NOT CONFIRMED. MANUFACTURING PROCESS WAS REVIEWED, IT WAS OBSERVED FIXTURE M1237 IS USED TO AVOID OCCLUSION DEFECT BY LETTING POSITIVE AIR PRESSURE FLOW INSIDE THE TUBE, WHILE IS BEING DIPPING INTO THE SOLVENT, TO AVOID THE SOLVENT GETTING TOUCH WITH THE INTERNAL WALLS OF THE TUBE AND CAUSING OCCLUSION. ACCORDING TO MANUFACTURING ROUTINE, THE POSITIVE AIR PRESSURE OF THE FIXTURE MUST BE SET AT 0.021 +/- 0.003 MPA, IT WAS OBSERVED THAT THE MANOMETER USED DOES NOT HAVE THE CORRECT RESOLUTION AND THEREFORE THE OPERATOR COULD NOT SET IT ACCORDINGLY. CONCLUSION: IT WAS CONCLUDED THAT THE MOST LIKELY ROOT CAUSE OF LACK OF SOLVENT DEFECT, IS RELATED TO THE AIR PRESSURE NOT BEING SET TO ESTABLISHED PRESSURE RANGE AND CAUSING THE AIR TO PRODUCE A LOT OF BUBBLES AND MAKING DIFFICULT FOR THE OPERATOR TO OBSERVED IF THE EXTERNAL WALLS OF THE TUBE WERE TOTALLY IMPREGNATED OF SOLVENT. ACTION TAKEN: A MANOMETER WAS CHANGED TO A DIGITAL TYPE THAT DISPLAYS ACCURATE AIR PRESSURE. AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD AND COMPLETED. CONCLUSION: THE ROOT CAUSE OF THE LEAKAGE FOUND IN THE FILTER IS RELATED TO A SUPPLIER ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH LOW CBS HAD IV FLUIDS NOTED TO BE LEAKING BELOW THE FILTER. THE FILTER SET WAS CHANGED AND NO MORE LEAKING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017008 MEDEX INTRAVASCULAR ADMINISTRATION SET FPB SMITHS MEDICAL ASD, INC. FS113 4185124 10351688510983

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown