BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 7250688 · Received February 8, 2018

    Report

    Report Number
    8010762-2018-00045
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 18, 2018
    Report Date
    May 23, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). THE ROTAFLOW DRIVE WAS INVESTIGATED BY THE MANUFACTURER EMTEC: DIAGNOSIS OF EMTEC:" NO ERRORS OR PROBLEMS WERE FOUND. THE RFD HAS PASSED ALL TESTS." THE DEVICE WAS ALSO CHECKED BY THE GETINGE FIELD SERVICE TECHNICIAN: READING ROTAFLOW DRIVE WAS CORRECT. NO ISSUES DURING TEST. SYSTEM TEST PERFORMED ACCORDING TO THE SERVICE PROTOCOL. THE FAILURE WAS NOT REPRODUCIBLE. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS AS A SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED. 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- MAQUET MEDICAL SYSTEMS USA, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON- (B)(4). THIS COMPLAINT WILL BE CLOSED BECAUSE OF LACK OF INFORMATION OF THE SSU SENT VIA EMAIL ON THE 2018-05-16. IF NEW INFORMATION WILL BE RECEIVED THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 0

    INTERNAL REFERENCE: (B)(4). AUTONUMBER:(B)(4).

    Description of Event or Problem · 0

    INTERNAL REFERENCE: (B)(4). AUTONUMBER:(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

    (B)(4). DURING PATIENT TREATMENT THE LPM OF THE ROTAFLOW IS OFF. NO PATIENT INJURY. THE ROTAFLOW DRIVE AND THE ROTAFLOW CONSOLE [COMPLAINT (B)(4)] AND WILL BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101197 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW DRIVE

    Patients

    Seq Age Sex Outcome Treatment
    1