BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURY PERFUSION PUMP

    MDR report key: 17528309 · Received August 12, 2023

    Report

    Report Number
    MW5135240
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    February 13, 2013
    Manufacturer
    CENTURY HLM, LLC
    Product Code
    DWB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT WHEN THE PUMP (CENTURY PERFUSION PUMP, SERIAL NUMBER (B)(6)) WAS TURNED ON IT BEGAN SOUNDING ALARMS. IT WAS RESET AND REMAINED IN OPERATING CONDITION. THE ARTERIAL PUMP STOPPED AND PRODUCED ERRORS E-30, E-22, E-21, ETC. AFTER RESETTING, IT CONTINUED TO EXHIBIT ERRORS. MOMENTARILY PERFUSION WAS MAINTAINED ON THE PEDIATRIC PATIENT BY HAND, PRESERVING VALUES WITHIN PHYSIOLOGICAL RANGES FOR THE PATIENT'S CONDITION. PERFUSION WAS RESUMED WITH THE PUMP BUT STOPPED AGAIN PRESENTING ERRORS OF SENSORS AND BUBBLES OF FIRST ARREST NIVEL. AFTER THAT, THE PUMP WAS LEFT ON WITHOUT ANY SENSOR. THE COMPUTER OPERATION WAS TURNED OFF AND LEFT IN MANUAL MODE. PERFUSION WAS RESUMED. THE CASE WAS COMPLETED WITH NO PATIENT INJURY OR CONSEQUENCE. THE SERVICE REPRESENTATIVE WAS CALLED AND EVALUATED THE PUMP FINDING NO FAULT. THE NEXT DAY, THE PUMP WAS STARTED IN THE PRESENCE OF THE PROMEX TECHNICIAN AND IT STOPPED AGAIN. HANDCRANK WAS USED FOR 15 MINUTES. THE OPERATOR RESET THE PART AND STOPPED PERFUSION. THE PATIENT WAS REMOVED FROM BYPASS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THIS SECOND CASE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244814 CENTURY PERFUSION PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE DWB CENTURY HLM, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown