BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 7361893 · Received March 22, 2018

    Report

    Report Number
    8010762-2018-00105
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 26, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    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).

    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). CONTACT PERSON: (B)(6) PLEASE NOTE THE REPORTED FAILURE WAS ACTUALLY NOT REPORTABLE! NO ADVERSE EVENT! AFTER CONSIDERING THE FAILURE DESCRIPTION OF THE INITIAL COMPLAINT REPORT AGAIN, THE REPORTABLE FAILURE (LEAKAGE ON THE DIALYSIS LOCK AND VALVE) IS NOT REPORTABLE. THE LEAK ON DIALYSIS LOCK WAS DETECTED DURING USE ON A PATIENT BUT THE AFFECTED OXY WAS USED UNTIL THE END OF THE THERAPY. THERE WAS NO EXCHANGE OF THE AFFECTED OXYGENTOR. THEREFORE THE REPORTING DECISION HAS TO BE CHANGED TO NOT REPORTABLE. THERE IS A MALFUNCTION OF THE DEVICE INVOLVED (LEAKAGE) BUT THIS MALFUNCTION DOES NOT AND IS NOT LIKELY TO CAUSE A HARM TO THE PATIENT. THE PRODUCT WAS INVESTIGATED IN THE LABORATORY BY THE MANUFACTURER. THE RETURNED COMPLAINT SAMPLE WAS AFTER RINSING WITH WATER AND A CLEANING WITH SODIUM HYPOCHLORITE, A VISUAL INSPECTION AND A LEAK TEST ACCORDING TO LV 201 (BLOOD SIDE) PERFORMED. THE RESULTS OF THE INVESTIGATION WERE DOCUMENTED. THE LEAK TEST ACCORDING TO LV 201 (BLOOD SIDE) WAS PERFORMED AND ON THE BLOOD OUTLET CONNECTOR (1/4 CONNECTOR) A LEAK (CRACKS) WAS DETECTED. AND THE LEAKAGE ON THE DIACONNECTOR PORT CAN BE CONFIRMED. THUS THE REPORTED FAILURE COULD BE CONFIRMED. THUS THE MOST PROBABLE CAUSE OF THE REPORTED FAILURE REMAINS UNCLEAR AT THIS TIME. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE HOSPITAL:"DURING A REGULAR SURGERY FOR THE GREAT ARTERY CASE, IT WAS FOUND THAT BLOOD WAS LEAKING FROM THE DIALYSIS LOCK VALVE. THE CUSTOMER HAS NEVER TOUCHED THE DIALYSIS LOCK VALVE THROUGH THE PRIMING OF THE SURGERY. THIS WAS THE FIRST CASE OF LEAKING FROM THE DIALYSIS LOCK VALVE AT THIS HOSPITAL. THE CUSTOMER STAYED ON THE SAME DEVICE. NO ADVERSE EFFECTS ON THE PATIENT. THE INCIDENT OCCURRED DURING PATIENT USE." (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203671 OXYGENATOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BO-VKMO 70000 92230612

    Patients

    Seq Age Sex Outcome Treatment
    1