BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2002509 · Received January 28, 2011

    Report

    Report Number
    1219856-2011-00030
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP SHUT DOWN DURING TRANSPORT. A MEMBER OF THE QUALITY DEPARTMENT AT THE FACILITY ASKED THE CLINICAL SUPPORT SPECIALIST (CSS) IF THERE WAS A NOTIFICATION ON THE PUMP WHEN THE BATTERY WAS RUNNING LOW. THE CSS CONFIRMED THAT THERE IS A COMMUNICATION BOX THAT POPS UP ON THE MONITOR AS THE BATTERY LIFE IS DIMINISHING. THE CSS WILL ALSO CONTACT THE FIELD SERVICE REPRESENTATIVE (FSR), SO HE CAN ASCERTAIN IF THIS PUMP NEEDS SERVICING AT THIS TIME. ADDITIONAL INFORMATION RECEIVED FROM THE FSR ON 01/11/2011 STATED THAT "THE QUALITY DEPARTMENT MEMBER AT THE FACILITY EMAILED SOME STRIPS IN TO BE LOOKED AT. PRETTY MUCH EVERYONE AGREES IT WAS OPERATIONAL ERRORS; KINKED CATHETER, ETC. FSR IS PLANNING TO CHECK THE PUMP OUT ON SITE JUST AS A PRECAUTION." FURTHER INFORMATION RECEIVED FROM THE QUALITY DEPARTMENT MEMBER AT THE FACILITY ON 01/17/2011 STATED THAT THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN