BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA & CATHETER

    MDR report key: 10499445 · Received September 7, 2020

    Report

    Report Number
    8010762-2020-00289
    Event Type
    Malfunction
    Date Received
    September 7, 2020
    Date of Event
    August 28, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RECEIVED BACK FOR INVESTIGATION. CANNULA WAS CLEANED ACCORDING TO PROCEDURE LV 205. CANNULA WAS INSPECTED VISUALLY UNDER MICROSCOPE AND WITH THE EXCEPTION OF A FEW MINIMAL DENTS IN THE PLASTIC LAYER OF THE DRAINAGE ANNULAR, NO ABNORMALITIES COULD BE OBSERVED. THE PROVIDED PICTURES FROM THE LABORATORY INVESTIGATION SHOWS THAT CANNULA HAS NO OBVIOUS FUNCTIONAL DEFECTS WHAT COULD HAVE RESULTED IN TO THE ISSUES AT THE INSERTION. FROM THE TECHNICAL POINT OF VIEW (BASED ON THE MICROSCOPE IMAGES), THE CANNULA IS NOT ASSUMED TO HAVE A DYSFUNCTION. THE CLOSED ¿BUBBLES¿ (IN THE PVC CANNULA BODY; ALSO VISIBLE IN THE IMAGES) ARE NOT KNOWN TO HAVE NEGATIVE IMPACT WHILE THE INSERTION (AND IN GENERAL). A GETINGE EMPLOYEE WAS ALSO AT THE EVENT SITE AT THE TIME EVENT OCCURRED. IT WAS REPORTED THAT FOR BETTER DILATION AN INSERTION AID WAS USED AND INSERTION PROCESS WAS PERFORMED PROPERLY. NO ANY ABNORMALITY WAS DETECTED WITH THE ANNULAR. AFTER PHYSICIAN FELT RESISTANCE, DIDN'T INSERT THE CANNULA TOO MUCH FORCE. NO HARM TO PATIENT OR USER WAS REPORTED. THE SECOND CANNULA WAS EASILY INSERTED THROUGH THE SAME INSERTION SITE WITHOUT ANY PROBLEMS BY PHYSICIAN. BASED ON THE INFORMATION OBTAINED SO FAR WITHIN THIS INVESTIGATION THAT IT COULD BE CONCLUDED THERE IS NO DEVICE PROBLEM. THE REPORTED FAILURE IS IDENTIFIED AS PART CURRENT RISK MANAGEMENT FILE DMS #1992719 V04 AND CHAPTERS H2.2.10, H2.4.4, H2.4.11, H2.4.12, H2.4.14, H2.4.19. THE MOST PROBABLE CAUSES ARE ASSOCIATED WITH WRONG DESIGN AND USER ERROR. MITIGATIONS FOR THIS SPECIFIC FAILURE ARE IN PLACE PER DESIGN SPECIFICATION AND INSTRUCTION FOR USE. POSSIBLE USE ERROR CAN BE LISTED AS: TOO MUCH FORCE ON CANNULA; CANNULA AND INTRODUCER ARE INTRODUCED TOO FAR INTO THE VESSEL; USER CHOOSES WRONG SIZE OF CANNULA. IT WAS STATED DURING INVESTIGATION THAT CUSTOMER DIDN'T INSERT THE CANNULA TOO DEPTH AND DIDN'T APPLY TOO MUCH FORCE AND THE SIZE OF THE CANNULA IS APPROPRIATE SINCE SECOND CANNULA WAS SAME SIZE. BASED ON THE INFORMATION ABOVE THE MOST PROBABLE CAUSE COULD BE USER INTERACTION - INAPPROPRIATE MOVABILITY OF CANNULA AND INTRODUCER IN VESSEL DURING INSERTION. THE USER ERROR IS MITIGATED WITH BELOW INFORMATION IN THE INSTRUCTION FOR USE: -A LACK OF KNOWLEDGE ON USE OF THE DEVICE CAN RESULT IN SERIOUS INJURIES OR DEATH. -THE DEVICE MUST ONLY BE USED BY AN EXPERIENCED / TRAINED PHYSICIANS. -THE PHYSICIAN IN CHARGE OF TREATMENT IS RESPONSIBLE FOR THE PROCEDURE AND CORRECT USE OF THE DEVICE. -THE PHYSICIAN MUST BE EXPERIENCED IN VESSEL CANNULATION PROCEDURES AND THE PROPER HANDLING OF COMPLICATIONS. -WITHIN THE INTENDED FLOW RATE, THE DEVICE CAN BE USED FOR ALL PATIENTS IRRESPECTIVE OF AGE, BODY WEIGHT AND GENDER. -THE DEVICE IS INTENDED TO BE USED IN A CLINICAL ENVIRONMENT UNDER ASEPTIC CONDITIONS. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. DEVICE HISTORY RECORD FOR LOT 92256006 WAS REVIEWED. THERE ARE NO EVIDENCES INDICATING NON-CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT: #(B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    "THE VENOUS ECLS DRAINAGE CANNULA CANNOT BE ADVANCED INTO THE VESSEL AFTER APPROPRIATE PREPARATION. USERS FELT STRONG RESISTANCE FROM THE SYSTEM. A SECOND CANNULA COULD EASILY BE ADVANCED THROUGH THE SAME PUNCTURE SITE." COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963982 CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PVS 2338#BE-HLS CANNULA 23F VS 92256006

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR