BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETERS & CANNULAE

    MDR report key: 8923480 · Received August 22, 2019

    Report

    Report Number
    8010762-2019-00259
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    June 20, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH WAS REQUESTED PRODUCT BACK FOR INVESTIGATION ON 2019-09-04. PRODUCT WAS SENT ON 2019-09-19. PRODUCT WAS RECEIVED ON 2019-09-30. ACCORDING TO DECLARATION OF INFECTION RISK RECORD, THE PRODUCT CONTAINS BIOLOGICAL RESIDUE OF WORLD HEALTH ORGANIZATION RISK GROUP 3 SUCH AS HIV, HEPATITIS A OR B WHICH MAY BE INFECTIOUS AND THERE IS HIGH INDIVIDUAL RISK. HENCE THE TECHNICAL INVESTIGATION CANNOT BE CARRIED OUT IN THE LABORATORY. AT THIS TIME NO SIMILAR COMPLAINT SAMPLE INVESTIGATED WAS FOUND. THE INVESTIGATION WAS DONE BASED ON THE VIDEO TAKEN BY USER. IT WAS CONFIRMED THAT THE DEFECTIVE PART IS CONNECTOR ITSELF BY SALES SERVICE UNIT RESPONSIBLE. LEAKAGE COULD BE SEEN BETWEEN THE CANNULA END AND THE CONNECTOR. FAILURE IS CONFIRMED. DEVICE HISTORY RECORD 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) AND THE MOST POSSIBLE ROOT CAUSE IS ASSOCIATED TO LACK OF ATTENTION OF USER AND/OR MANUFACTURING. MITIGATIONS FOR THIS SPECIFIC FAILURE ARE IN PLACE IN INSTRUCTION FOR USE AND PROCESS RISK ASSESSMENT DOCUMENTS. MITIGATIONS: IFU: A LACK OF KNOWLEDGE ON USE OF THE DEVICE CAN RESULT IN SERIOUS INJURIES OR DEATH. THE DEVICE MUST ONLY BE USED BY AN EXPERIENCED PHYSICIAN. THE PHYSICIAN IN CHARGE OF TREATMENT IS RESPONSIBLE FOR THE PROCEDURE AND CORRECT USE OF THE DEVICE. IFU: DAMAGE TO THE DEVICE OR PACKAGING. A NON-STERILE OR DEFECTIVE DEVICE CAN RESULT IN PATIENT INFECTIONS. PERFORM A CAREFUL VISUAL INSPECTION OF THE STERILE PACKAGING BEFORE USE. PAY PARTICULAR ATTENTION TO MOISTURE, OPENINGS AND SOILING. PERFORM A CAREFUL VISUAL INSPECTION OF THE DEVICE BEFORE USE. IN PARTICULAR, ENSURE THERE IS NO DAMAGE TO THE MATERIAL, CRACKS, BURRS OR FISSURES. PROCESS RISK ASSESSMENT: 100% CONTROLS OF DAMAGE OF THE INSERTED PARTS DURING MANUFACTURING. IN THIS CASE, A CRACK OR A BROKEN CONNECTOR COULD BE CAUSED THE LEAK. THE REPORTED FAILURE DID NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. OUR EMPLOYEES ARE INFORMED REGARDING THIS CASE AND REMINDED TO RELATED BASIC OPERATION PROCEDURE 9204402 BY GETINGE CARDIOPULMONARY ANTALYA. NO FURTHER ACTIONS IN THE FIELD ARE REQUIRED. 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

    COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 1

    SCRAPPED BY USER.

    Description of Event or Problem · 1

    ON JUNE 20, A CANNULA BROKE WHEN IT WAS INSERTED INTO THE PATIENT AT THE JUNCTION BETWEEN THE CANNULA AND THE CONNECTOR. FORTUNATELY, THE PROBLEM WAS IDENTIFIED BEFORE THE CANNULA AND THE CIRCUIT WERE UNCLAMPED. THEN, THE DEFECTIVE PART WAS CUT OFF AND A NEW CONNECTOR WAS INSERTED AND CRIMPED, THE CIRCUIT CONNECTED TO THIS FITTING AND THE ECMO TURNED WITHOUT PROBLEMS. THE DOCTOR IS USED TO USING THIS PRODUCT AND THIS IS THE FIRST TIME HE IS CONFRONTED WITH THIS PROBLEM. THIS PHENOMENON HAS NOT BEEN REPEATED SINCE. COMPLAINT: # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714955 CATHETERS & CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PVL 2955# 92234083

    Patients

    Seq Age Sex Outcome Treatment
    1