BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA & CATHETER

    MDR report key: 12323470 · Received August 16, 2021

    Report

    Report Number
    8010762-2021-00448
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    August 11, 2021
    Report Date
    October 20, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS BLOOD LEAK AT THE CONNECTOR OF HLS CANNULA DUE TO CRACKS IN THE LUER LOCK PART. IT WAS DETECTED DURING USE ON PATIENT. NO HARM OR DEATH WAS REPORTED. THE HLS CANNULA WAS RECEIVED FOR INVESTIGATION. A CRACK ON THE LUER COULD BE SEEN. THE CAP FOR THE LUER WAS NOT INCLUDED IN THE DELIVERY. THE AIR PRESSURE-FILLED LEAK TEST UNDER WATER SHOWED THE FIRST AIR BUBBLES AT APPROXIMATELY 10 MBAR. BASED ON THIS FAILURE COULD BE CONFIRMED. DEVICE HISTORY RECORD FOR LOT NUMBER 3000149924 WAS REVIEWED. THERE ARE NO EVIDENCES INDICATING NON-CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. 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 CAUSE COULD BE DETERMINED AS USER ERROR-UNINTENDED STRAIN ON THE PRODUCT AND MECHANICAL DAMAGE. IT WAS ALSO REPORTED IN THIS COMPLAINT THAT THE PRESSURE MIGHT HAVE BEEN MADE SLIGHTLY WHEN CONNECTING A DISTAL PERFUSION CANNULA. 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

    COMPLAINT # : (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLOOD LEAK AT THE CONNECTOR OF HLS CANNULA DUE TO CRACKS IN THE LUER LOCK PART. IT WAS DETECTED DURING USE ON PATIENT. COMPLAINT # :(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223061 CANNULA & CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAS 1515#BE-HLS CANNULA 15F AS 3000149924

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR