BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA & CATHETER

    MDR report key: 14191732 · Received April 25, 2022

    Report

    Report Number
    8010762-2022-00124
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    December 16, 2020
    Report Date
    May 18, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    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

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BLEEDING WAS OCCURRED DUE TO A CRACK AT THE CONNECTING END OF HLS CANNULA. THE FAILURE WAS NOTICED ON 2020-12-16 AFTER CANNULA WAS GIVEN TO PATIENT ON 2020-12-13. THE PRODUCT WAS REPLACED. AFTER THE REPLACEMENT, THE PROBLEM WAS SOLVED AND NO SERIOUS INJURY WAS CAUSED. THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. A VISUAL (PHOTOGRAPH OR VIDEO) ALSO COULD NOT BE PROVIDED SHOWS THE FAILURE. IT COULD NOT BE DETECTED WHICH PART OF THE CONNECTOR HAD THE CRACK HOWEVER IT WAS REPORTED THAT WAS A CRACK AT THE CONNECTING END. SINCE THE PRODUCT HAD TO BE CHANGED, THE COMPLAINT COULD BE CONFIRMED. THE CUSTOMER COULD NOT PROVIDE THE LOT NUMBER OF THE AFFECTED HLS CANNULA. THEREFORE, THE DHR REVIEW COULD NOT BE PERFORMED. THE EXACT CAUSE OF THE CRACK COULD NOT BE DETERMINED. HOWEVER, THE REPORTED FAILURE COULD BE LINKED TO THE RISK ASSESSMENT AND CONTROL - HLS CANNULAE (DMS #1992719, V04) AND THE MOST PROBABLE CAUSES ARE: TRANSPORT & STORAGE; MECHANICAL DAMAGE OF PRODUCT ; USER ERROR: LACK OF ATTENTION; - MECHANICAL DAMAGE OF CANNULA CONNECTION; - UNINTENDED REPOSITIONING (E.G. DURING PATIENT TRANSPORT OR REPOSITIONING) . 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 THE BLEEDING WAS OCCURRED DUE TO A CRACK AT THE CONNECTING END OF HLS CANNULA. THE FAILURE WAS NOTICED ON 2020-12-16 AFTER CANNULA WAS GIVEN TO PATIENT ON (B)(6) 2020. THE PRODUCT WAS REPLACED. THE CONNECTING TUBE WAS REPLACED. AFTER THE REPLACEMENT, THE PROBLEM WAS SOLVED AND NO SERIOUS INJURY WAS CAUSED. COMPLAINT: #(B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195986 CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAL 1723#BE-HLS CANNULA 17F AL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male