BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 23377818 · Received October 24, 2025

    Report

    Report Number
    8010762-2025-0000473
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING INSERTION OF HLS CANNULAE, THE CANNULA BODY WIRES WERE BENDING AND KINKED. FURTHER, IT WAS ALSO REPORTED THAT THE DILATOR TIP WAS SPLIT DURING THE ATTEMPT OF DILATE TO BLOOD VESSEL. THIS SECOND REPORTED FAILURE WILL BE INVESTIGATED WITHIN COMPLAINT ONETRACK #(B)(4) (MFG REPORT NUMBER: 8010762-2025-0000474). NO HARM TO ANY PERSON WAS REPORTED. THE CUSTOMER INFORMED THE DISTRIBUTOR AS NO MORE INFORMATION WILL BE PROVIDED. THEREFORE, NEITHER A LOT NUMBER NOR A CLEAR PICTURE / SAMPLE COULD BE GATHERED WITHIN THE COMPLAINT. BASED ON THE INVESTIGATION RESULTS, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED FAILURE HOWEVER THE REPORTED FAILURE MIGHT BE RELATED WITH RISK ASSESSMENT FILE OF THE PRODUCT AND POSSIBLE CAUSES ARE AS FOLLOW: MANUFACTURING: - USE OF WRONG OR OUT OF SPEC MATERIALS TRANSPORT / STORAGE: - MECHANICAL DAMAGE OF THE PRODUCT DUE TO VIBRATION AND IMPACT USER: - MECHANICAL DAMAGE OF CANNULA OR INTRODUCER DURING INSERTION OF INTRODUCER - INAPPROPRIATE MOVABILITY OF CANNULA AND INTRODUCER IN VESSEL DURING INSERTION - THE USER DIDN´T PERCEIVE OR RECOGNIZE HOW TO HANDLE THE CANNULA OR WAS NOT ABLE TO HANDLE THE CANNULA APPROPRIATELY. THESE ROOT CAUSES COULD NOT BE CONFIRMED. THE REPORTED FAILURE IS COVERED IN BASIC OPERATION PROCEDURE, BOP 9204400, V01 VISUAL INSPECTION OF CANNULAE: 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, REVIEW OF THE NON-CONFORMITIES DID NOT SHOW ANY NON-CONFORMITY RECORD WHICH IS DIRECTLY RELATED TO BENT / KINK OF CANNULA BODY. FURTHER, THERE COULD NOT BE FOUND A KINK / BENT CANNULA BODY COMPLAINT IN ONE YEAR TREND SEARCH. DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER OF THE REPORTED PRODUCT WAS NOT PROVIDED BY CUSTOMER. BASED ON THE RESULTS THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION OF HLS CANNULAE, THE CANNULA BODY WIRES WERE BENDING AND KINKED. FURTHER, IT WAS ALSO REPORTED THAT THE DILATOR TIP WAS SPLIT DURING THE ATTEMPT OF DILATE TO BLOOD VESSEL. THIS SECOND REPORTED FAILURE WILL BE INVESTIGATED WITHIN COMPLAINT ONETRACK # (B)(4). NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE OCCURRED DURING TREATMENT, AND THE KINKED CANNULA BODY COULD CAUSE HAZARDOUS SITUATION VESSEL DAMAGE, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336354 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other