BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

    MDR report key: 10123975 · Received June 5, 2020

    Report

    Report Number
    8010762-2020-00192
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    May 28, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH DID NOT REQUEST THE PRODUCT BACK FOR INVESTIGATION SINCE THERE ARE PHOTOGRAPHS OF THE FAILURE. IN THESE PHOTOGRAPHS, IT COULD BE SEEN THAT THERE IS CRACK AT THE LUER PART OF THE CONNECTOR. MAQUET CARDIOPULMONARY GMBH IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCT, SHOWING A SIMILAR MALFUNCTION, HAS BEEN INVESTIGATED IN #265320: ACCORDING TO THIS INVESTIGATION, VISUAL INSPECTION WAS PERFORMED. AT THE LUER CONNECTOR SEVERAL CRACKS AND HAIRLINE CRACKS WERE DETECTED. BASED ON THIS FAILURE COULD BE CONFIRMED. TREND SEARCH WAS PERFORMED. AT THIS TIME NO SYSTEMIC ERROR WAS FOUND. AT THIS TIME, NO POORLY DESIGNED DEVICE PROBLEM WAS DETECTED. DEVICE HISTORY RECORD FOR LOT 92291140 WAS REVIEWED. THERE ARE NO EVIDENCES INDICATING A NON CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING THE MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE REPORTED FAILURE WAS IDENTIFIED AS PART OF THE CURRENT RISK MANAGEMENT FILE (DMS#1992719 V3B). MITIGATION'S FOR THIS SPECIFIC FAILURE ARE IN PLACE AS PER INSTRUCTION FOR USE WARNINGS AND DESIGN SPECIFICATIONS AND ALSO IN MANUFACTURING PROCESSES IN ORDER TO REDUCE OF SIMILAR FAILURES. IT WAS REPORTED THAT THE FAILURE WAS OCCURRED 3 DAYS AFTER INSTALLATION. THE CANNULAE WAS USED WITH MAQUET BE-HLS 7050#HLS SET ADVANCED. THIS INFORMATION SHOWS THAT THE PRODUCT HAS NO DAMAGE AT THE TIME RECEIVED BY CUSTOMER. BASED ON THIS NO MANUFACTURING PROBLEM COULD BE DETECTED. ACCORDING TO INSTRUCTION FOR USE, THE MAXIMUM DURATION OF USE FOR THE HLS CANNULAE WITH BIOLINE COATING IN COMBINATION WITH A PLS SET, PLS SET PLUS OR HLS SET ADVANCED FROM MAQUET IS 30 DAYS. BASED ON THIS, NO USE DURATION PROBLEM COULD BE DETECTED. THE INFORMATION OBTAINED SO FAR WITHIN THIS INVESTIGATION DOES NOT REPRESENT ANY USE, DESIGN AND MANUFACTURING PROBLEMS. I COULD BE CONFIRMED THAT THE DEVICE MET ITS SPECIFICATION AT THE TIME OF MANUFACTURING AND THEREFORE ALL DAMAGES FOUND ON THE PRODUCT ARE DUE TO EXCESSIVE OR INADEQUATE EXTERNAL PHYSICAL FORCE THAT WAS EXERTED ON THE PRODUCT AFTER THE RELEASE. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY GMBH AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "PROBLEM WITH A 17FR ARTERIAL CANNULA ON THE REPERFUSION CONNECTION THAT CRACKED FAILURE ON THE LUER LOCK CONNECTION." COMPLAINT: #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589236 CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAS 1715#BE-HLS CANNULA 17F 92291140

    Patients

    Seq Age Sex Outcome Treatment
    1