BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

    MDR report key: 7264865 · Received February 12, 2018

    Report

    Report Number
    8010762-2018-00050
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 18, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K141432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). INVESTIGATION WAS PERFORMED BASED ON SIMILAR COMPLAINT(B)(4) .IT CAN BE CLEARLY SEEN THAT THERE IS A LEAKAGE BETWEEN THE 70104.5749 TUBE AND 70105.2890 ADAPTER TUBE.BASED ON THIS FAILURE COULD BE CONFIRMED. SAP TREND SEARCH WAS PERFORMED (MATERIAL 70104.9279, FAILURE CODE 0122 TUBING SET CONNECTION) WHICH CAME TO FOLLOWING RESULTS:0 ADDITIONAL COMPLAINTS WERE RECORDED SINCE THE LAST 12 MONTHS.BASED ON THE SALES FIGURES OF THE LAST 12 MONTHS FOLLOWING OCCURRENCE RATE HAS BEEN CALCULATED: (B)(4) , WHICH IS BELOW THAN 1%.DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED.ALSO MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR ISSUES WHICH WERE RECORDED WITH DIFFERENT MATERIAL NUMBERS AND FAILURE CODES.THEREFORE GETINGE CP ANTALYA HAS BEEN INITIATED A CAPA BASED ON SEVERAL COMPLAINTS SHOWING THE SAME SYMPTOMS WITH DIFFERENT MATERIAL NUMBERS THAN THE ONE IN THIS COMPLAINT, IN ORDER TO DETERMINE THE ROOT CAUSE AND INITIATE FURTHER ACTIONS TO DETERMINE CORRECTIVE MEASURES FOR THE FAILURE.ALL FURTHER STEPS WILL BE PERFORMED IN ACCORDANCE TO CAPA 2015/03.THIS COMPLAINED PRODUCT WAS MANUFACTURED BEFORE THE CORRECTIVE ACTIONS ARE IMPLEMENTED IN CAPA 2015/03.DEVICE HISTORY RECORD WAS REVIEWED.THERE WERE NO REFERENCES FOUND WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. AS A CORRECTIVE ACTION, CAPA (B)(4) HAS BEEN ALREADY INITIATED TO ADDRESS THE APPROPRIATE CORRECTIVE/PREVENTIVE ACTIONS. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS.DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002 IMPORTER- (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REF.: #(B)(4).

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (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 IS BLOOD LEAKAGE FROM THE ONE-WAY VALVE CONNECTION DURING PATIENT USE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106156 RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG VKMO 11000 92232921

    Patients

    Seq Age Sex Outcome Treatment
    1