BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 20030704 · Received August 22, 2024

    Report

    Report Number
    8010762-2024-00412
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 11, 2024
    Report Date
    November 11, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691582573
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TIP OF THE 19FR CANNULA WAS BLUNT AND NOT ABLE TO FLUSH SMOOTHLY WITH THE STYLET AND HENCE RENDER FEMORAL ARTERY CANNULATION DIFFICULT VIA SELDINGER TECHNIQUE. THE FAILURE DETECTED DURING TREATMENT. POTENTIAL FOR HARM IS REPORTED. THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2024-11-04. A VISUAL INSPECTION WAS PERFORMED AND NO DEFORMATION AND DAMAGE WERE OBSERVED ON THE PRODUCT. IN THE LABORATORY, A FUNCTIONALITY CHECK WAS DONE AND THE INTRODUCER WAS ABLE TO MOVE WITH LESS RESISTANCE TO THE DEDICATED POSITION (IN THE CANNULA). THE SAME CAN BE STATED FOR EXTRACTION OF THE INTRODUCER FROM THE CANNULA. NO DEFECT COULD BE DETECTED. THE DIMENSIONAL CHECK IN THE LABORATORY CONFIRMED THAT THE CANNULA TIP WAS WITHIN SPECIFICATION FOR THE INNER AND OUTER DIAMETERS FOR THE COMPLAINT CANNULA. THE FAILURE COULD NOT BE CONFIRMED. EXACT CAUSE COULD NOT BE DETERMINED, HOWEVER THE REPORTED FAILURE IS IDENTIFIED AS PART OF CURRENT RISK MANAGEMENT FILE AND THE PROBABLE CAUSE OF THE FAILURE AS FOLLOW: MECHANICAL DAMAGE OF INTRODUCER (TIP) AND/OR CANNULA DURING RETRACTION. THIS CAUSE COULD NOT BE CONFIRMED. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BE-PAS 1915#BE-HLS CANNULA 19F AS WITH LOT# 3000316353 WAS REVIEWED ON 2024-10-10. ACCORDING TO THE DHR RESULT, THE PRODUCT BE-PAS 1915#BE-HLS CANNULA 19F AS PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. FURTHER, THE INCOMING INSPECTION REPORT OF THE AFFECTED MATERIAL #701046341 FEM BODY19_AS-01#PERI.CATH.BODY 19FR, AS (WITH BATCH #3000278867, #3000278868 AND #3000278869) WERE REVIEWED ON 2024-10-10. FEM BODY19_AS-01#PERI.CATH.BODY 19FR, AS WAS CHECKED VISUALLY FOR PACKAGING CLEANING, PARTICLES, RIDGES, SHARP EDGES, CRACKS, STREAKS, DIRT, SPOTS, OPEN BUBBLES, COIL. ALL TESTS WERE PASSED AS PER SPECIFICATIONS. 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. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    REPORTED FAILURE: IT WAS REPORTED THAT THE TIP OF THE 19FR CANNULA WAS BLUNT AND NOT ABLE TO FLUSH SMOOTHLY WITH THE STYLET AND HENCE RENDER FEMORAL ARTERY CANNULATION DIFFICULT VIA SELDINGER TECHNIQUE. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE OCCURRED DURING TREATMENT AND THE REPORTED FAILURE COULD CAUSE HAZARDOUS SITUATION VESSEL DAMAGE, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127880 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAS 1915 #BE-HLS CANNULA 19F AS 3000316353 04037691582573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown