BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR

    MDR report key: 10383766 · Received August 10, 2020

    Report

    Report Number
    8010762-2020-00254
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 30, 2020
    Report Date
    October 26, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE "BAD OXYGENATION" OCCURRED DURING USE (APPROX. 3 HOURS FROM THE START). THE AFFECTED HMOD 70000 WITH LOT#70126870 WAS REQUESTED FOR FURTHER INVESTIGATION IN THE LABORATORY OF THE MANUFACTURER ON 2020-08-03. THE RETURNED PRODUCT WAS RECEIVED BY THE MANUFACTURER ON 2020-09-01. INVESTIGATION PLAN PREPARED AND FORWARDED TO PEM VIA EMAIL ON 2020-09-07. INVESTIGATION PLAN RECEIVED AND FORWARDED TO THE LABORATORY ON 2020-09-08. THE AFFECTED PRODUCT WAS INVESTIGATED IN THE LABORATORY ON 2020-10-26. LAB INVESTIGATION RESULTS: A VISUAL INSPECTION WAS PERFORMED. A TIGHTNESS TEST ACCORDING LV 201 WAS PERFORMED. A LEAK AT THE GAS OUTLET WAS DETECTED. A TEST ACCORDING TEST PLAN DTM031 IS THEREFORE NO LONGER NECESSARY. A TEST ACCORDING TO TEST PLAN DTM003 IS ONLY POSSIBLE WITH BLOOD DUE TO THIS THE TEST IS NOT POSSIBLE. CONCLUSION: THE RETURNED SAMPLE WAS INVESTIGATED AND A LEAK TEST IN ACCORDANCE WITH LV 201 WAS PERFORMED. A LEAK ON THE GAS OUTLET WAS DETECTED. IN THIS CASE, THE REPORTED FAILURE COULD BE CONFIRMED. DUE TO THE LEAK THROUGH THE GAS OUTLET A PRESSURE DROP MAY HAVE OCCURRED. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE "BAD OXYGENATION" COULD BE DETERMINED AS: INADEQUATE PUR ENCAPSULATION OF THE MATS CONSIDERED IN THE OXYGENATOR. DEVICE HISTORY RECORD(DHR)REVIEW WAS PERFORMED AND NO REFERENCES FOUND, WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. THE REPORTED FAILURE "BAD OXYGENATION" OCCURRED DURING USE AND COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE 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 ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WIL BE SUBMITTED WHEN ADITTIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CUSTOMER FROM (B)(6) THAT OXYGENATION ON THE HMO 70000 WAS NOT POSSIBLE DURING USE (APPROX. 3 HOURS FROM THE START). CUSTOMER DIDN´T MANAGE TO PUT STRESS ON QUADROX, AND CUSTOMER USED IT AS USUAL. THE PHENOMENON HAPPENED VERY SUDDENLY. THE OXYGENATOR WAS IMMEDIATELY IT WITH A NEW ONE. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851085 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMO 70000 #SQUADROX-I ADULT OHNE FILTER 70126870

    Patients

    Seq Age Sex Outcome Treatment
    1