BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 23346813 · Received October 21, 2025

    Report

    Report Number
    8010762-2025-0000468
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 17, 2025
    Report Date
    January 22, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691589657
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN ARTERIAL CANNULA WAS USED TO PLACE CATHETER FOR A 43-YEAR-OLD, MALE PATIENT SURGERY. DURING THE OPERATION, THE METAL PART OF THE BODY OF THE CANNULA WAS BROKEN. THEN, SURGEON REMOVED THE BROKEN CANNULA AND REPLACED IT WITH A NEW ONE. NO HARM TO ANY PERSON WAS REPORTED. THE PRODUCT WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2026-01-21. VISUAL INSPECTION REVEALS A DEFORMED AREA WHICH IS VERY CLOSED TO THE BROKEN AREA AND WHICH COULD BE OCCURRED BY AN ADDITIONAL FORCE LIKE CLAMP. BASED ON THE INVESTIGATION RESULTS, FAILURE COULD BE CONFIRMED HOWEVER PRODUCT RELATED INFLUENCES COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION RESULTS, THE MOST PROBABLE CAUSE WAS FOUND AS RELATED WITH USER ERROR: - PROVIDED SAMPLE SHOWS A DEFORMATION OF THE INNER METAL REINFORCEMENT THAT IS LIKELY THAT THE OPERATOR USED A CLAMP OUTSIDE OF THE DEDICATED "CLAMPING AREA TO BLOCK THE CANNULA. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BE-PAL 1723 WITH LOT# 3000434620 WAS REVIEWED ON 2025-10-30. ACCORDING TO THE DHR RESULTS, THE PRODUCT BE-PAL 1723 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AN NO ABNORMALITIES IN REGARD TO THE REPORTED FAILURE WERE FOUND. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED FAILURE. BESIDES, BASIC OPERATION PROCEDURE " VISUAL INSPECTION OF CANNULAE" INCLUDES BELOW 100% CONTROLS: 4.2. VISUAL INSPECTION OF THE HLS CANNULA. HLS CANNULAS SHALL BE VISUALLY INSPECTED UNDER 100% MAGNIFIER ACCORDING TO THE FOLLOWING ITEMS. - ALL REINFORCEMENT MATERIALS SHALL BE TOTALLY ENCAPSULATED IN POLYURETHANE. WIRE PROTRUSIONS AND POLYURETHANE SURFACE DEFORMATIONS ARE NOT ALLOWED. - THE SPRING COILS SHALL BE PARALLEL TO EACH OTHER AND ADJACENT COILS SHALL NOT TOUCH THE NEIGHBOURING WIRE. - THE GAPS BETWEEN SPRINGS SHALL BE HOMOGENEOUS ACCORDING TO THE TECHNICAL DRAWING. - THERE SHALL BE NO UNEMBEDDED FOREIGN MATERIAL (PARTICLES ETC.) ON THE HLS CANNULAE. - THE HLS CANNULAE SHALL BE FREE OF RIDGES, SHARP EDGES, CRACKS, FRACTURES OR SCRATCHES. - THERE SHALL NOT BE ANY BENDING AND KINK DEFORMATION ON THE REINFORCEMENT MATERIAL OF THE HLS CANNULA BODY. BESIDES, INCOMING INSPECTION REPORT OF THE RELATED CANNULA BODY HAS BEEN CHECKED FOR ANY POTENTIAL DETECTED DEFORMATION, ACCORDING TO THE INSPECTION RESULTS ALL TESTS WERE PASSED AS PER SPECIFICATION. INSTRUCTION FOR USE OF THE PRODUCT INCLUDES BELOW INFORMATION: ONLY CLAMP THE CANNULA AT THE PRESCRIBED POSITION. PLEASE OBSERVE THE CLAMPING SYMBOL. THE CUSTOMER WILL BE INFORMED BY SALES & SERVICE UNIT ABOUT THE INVESTIGATION RESULTS. 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

    IT WAS REPORTED THAT AN ARTERIAL CANNULA WAS USED TO PLACE CATHETER FOR A PATIENT SURGERY. DURING THE OPERATION, THE METAL PART OF THE BODY OF THE CANNULA WAS BROKEN. THEN, SURGEON REMOVED THE BROKEN CANNULA AND REPLACED IT WITH A NEW ONE. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE EVENT OCCURRED DURING TREATMENT / ON PATIENT USE AND THE PRODUCT CHANGE WAS REQUIRED, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283734 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAL 1723 3000434620 04037691589657

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other