BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 7289635 · Received February 22, 2018

    Report

    Report Number
    8010762-2018-00070
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS, USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY(B)(4). RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6). MAQUET CARDIOPULMONARY GMBH RECEIVED THE PRODUCT FOR INVESTIGATION.A CONTAMINATED QUADROX-I ADULT WAS RETURNED.PRODUCT WAS CLEANED WITH SODIUM HYPOCHLORITE. LEAK TEST WAS PERFORMED.LEAKAGE AT THE GAS OUTLET WAS DETECTED.NO FURTHER ABNORMALITIES NOTED.A LEAK AT THE GAS OUTLET CAN BE CONFIRMED.FURTHER INVESTIGATION STEPS ARE MOMENTARILY NOT POSSIBLE TO BE EXECUTED DUE TO WORK SAFETY ISSUES IN THE COMPLAINT LABORATORY.MAQUET CARDIOPULMONARY IS CURRENTLY IN THE MITIGATION OF THIS ISSUE.WHEN FURTHER INVESTIGATION STEPS CAN BE EXECUTED AGAIN, THESE INVESTIGATIONS WILL BE PERFORMED AND THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY.BASED ON THE INFORMATION ABOVE,THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME.DHR REVIEW RESULT:AFFECTED PRODUCT,BASIC LOT 70117968(SERIAL NUMBER(B)(4)), PACKAGING LOT 70117968.THE AVZ ART.NO. 70106.7789 PRODUCT 01970100 #SQUADROX-I ADULT OHNE FILTER FROM EKQ 430 TO EKQ 444(DMS# 2503163)WAS REVIEWED AND THERE WERE NO REFERENCES FOUND,WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION.BUT IN THE SAME AVZ ARE THREE MORE PRODUCTS WHICH SHOW A NONCONFORMANCE WITH THE GAS FIBER(EKQ 441, EKQ 436, EKQ 442)DURING THE PRESSURE TEST AND SOFTLINE COATING.ALL 3 WERE SCRAPPED.SAP TREND SEARCH WAS PERFORMED BASED ON (FAILURE CODE:0101 LEAKAGE GAS OUTLET FOR 01970110 QUADROX-I)WHICH CAME TO FOLLOWING RESULTS:4 ADDITIONAL COMPLAINTS WERE FOUND SINCE LAST 12 MONTHS.ALSO,TRACKWISE DATABASE TREND SEARCH WAS PERFORMED BASED ON PROBLEM LEVEL D-LEAKAGE/GAS OUTLET AND NO SIMILAR COMPLAINT WAS FOUND.BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED:0,017%,WHICH IS BELOW 1%.DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED.

    Description of Event or Problem · 0

    REF.: #(B)(4)., CUSTOMER REF.: #(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE HOSPITAL: "THERE WAS BLOOD LEAKING FROM THE GAS OUTLET." (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131514 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92238613

    Patients

    Seq Age Sex Outcome Treatment
    1