BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID ADULT

    MDR report key: 12030723 · Received June 21, 2021

    Report

    Report Number
    8010762-2021-00358
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    June 10, 2021
    Report Date
    September 3, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT WITH A QUADROX-ID THE CO2 REMOVAL RATE WAS LOW. OXYGENATION WAS IN RANGE. THE DEVICE WAS BEING USED FOR TREATMENT. AFTER COMMUNICATION WITH THE CUSTOMER IT WAS DETERMINED THAT A BLOOD TO GAS FLOW RATIO OF 1:4 WAS APPLIED DURING TREATMENT. ACCORDING TO THE QUADROX-ID ADULT INSTRUCTIONS FOR USE CHAPTER 6.3 "STARTING PERFUSION" A RATIO OF 1:1 WITH 80 % OXYGEN SHOULD BE USED. THE GAS FLOW SETTINGS SHOULD BE CHECKED SHORTLY AFTER BEGINNING PERFUSION. IF NEEDED ADJUST THE OXYGEN CONTENT AND THE GAS/BLOOD FLOW RATIO TO THE MEASURED VALUES. AS CONFIRMED BY THE CUSTOMER BY INCREASING THE SWEEP THE BLOOD VALUES WERE CORRECTED. THE PRODUCTION RECORDS OF THE AFFECTED QUADROX-ID MODULE (DMS# 2809340, 2790217) WERE REVIEWED ON 2021-09-03. FOLLOWING STEPS ARE PERFORMED ACCORDING TO THE BOP WITH A 100 % INSPECTION: PRESSURE TEST, TIGHTNESS TEST, COATING TEST. ACCORDING TO THE FINAL TEST RESULTS, THE OXYGENATOR WITH THE SERIAL# 1389717 PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE INVESTIGATION RESULTS NO MALFUNCTION OF THE QUADROX-ID COULD BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE 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

    FURTHER PATIENT AND PERFUSION DATA WAS REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CO2 REMOVAL OF A QUADROX-ID WAS LOWER THAN EXPECTED. DETAILED DESCRIPTION FROM CUSTOMER BELOW: PRE MEMBRAN OXYGENATOR (MO) BLOOD GAS WAS PH: 7.39, CO2:78, PO2 33 AND THE POST MO BLOOD GAS WAS PH: 7.42, CO2: 70, AND PO2: 250. THE CUSTOMER FELT LIKE THE POST MO CO2 SHOULD HAVE BEEN LESS THAN IT WAS ON 2 LPM OF SWEEP GAS. THIS IS COVID PATIENT THAT HAS BEEN ON THIS DISPOSABLE FOR 8 DAYS. THERE WAS NO PATIENT HARM AND THEY DO NOT PLAN TO CHANGE OUT THE DISPOSABLE. THEY PLAN TO INCREASE THE SWEEP GAS AND CHECK A GAS. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930310 QUADROX-ID ADULT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

    Patients

    Seq Age Sex Outcome Treatment
    1