BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4296325 · Received November 12, 2014

    Report

    Report Number
    8010762-2014-01234
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN REMOVED THE UNIT FOR SERVICE. THE REPORTED ALARM WAS CONFIRMED. THE BATTERY PACK WAS REPLACED. A SUPPLEMENTAL MEDWATCH WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON FRIDAY EVENING, (B)(6) 2014, THE CUSTOMER RECEIVED ERROR BTEMP AND THE PUMP STOPPED. THE CUSTOMER REPLACED THE ROTAFLOW WITH A BACK-UP UNIT SERIAL NUMBER (B)(4) AND WAS UNABLE TO ESTABLISH FLOW. CUSTOMER PUT INITIAL ROTAFLOW SERIAL NUMBER (B)(4) BACK ON THE PATIENT. THE PROBLEM RE-OCCURRED ONCE ON (B)(6) 2014. EACH TIME, POWER WAS CYCLED AND ERROR WAS CLEARED. AROUND 11:40 AM ON (B)(6) 2014, ALARM RE-OCCURRED. CUSTOMER SWAPPED OUT ROTAFLOW WITH ANOTHER BACK UP UNIT. NO ADVERSE EFFECT ON PATIENT. MEDWATCH REPORT # 8010762-2014-01233; IMP# (B)(4), REPORT # 8010762-2014-01235; IMP# (B)(4); REPORT # 8010762-2014-01071; IMP# (B)(4) AND REPORT #8010762-2014-01065; IMP# (B)(4). THIS REPORT IS FOR DEVICE 1 OF 2 AND EVENT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730306 ROTAFLOW CENTRIFUGAL PUMP SYSTEM KFM MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention