BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE ITALIAN

    MDR report key: 1587558 · Received January 13, 2010

    Report

    Report Number
    1219856-2010-00012
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    November 27, 2009
    Report Date
    January 13, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PER EXPEDITED QUALITY REVIEW REPORT: PUMP WAS ON PT. ERROR 8 NO COMMUNICATION. THE PUMP GAVE ERROR 8 A FEW HOURS AFTER THERAPY BEGAN. ACTIONS: THE FIBEROPTIX SENSOR ('FOS') BOARD & FRONT END BOARD ('FEB') WERE REPLACED. WHEN "WE CHECKED THE PUMP, IT WORKED CORRECTLY. IT ZEROED CORRECTLY, WE TRIED TO REPLACE THE FOS & THE ERROR 8 RESUMED. ADDITIONAL INFO RECEIVED ON 12/18/09 FROM THE SERVICE MGR ('SM') EXPLAINED IN MORE DETAIL WHAT HAPPENED TO THE PUMP, (B)(4). WHEN THE SM FIRST CHECKED THE PUMP, IT WAS ON A PT, WITH A "RED CROSS" ON FOS LIGHT BULB & ERROR 8 MESSAGE DISPLAYED ON LCD MONITOR. AFTER A FEW DAYS, THE SM RECEIVED A CALL FROM THE WARD INFORMING HIM THAT THE PUMP WAS NOT IN USE ANYMORE & WAS AVAILABLE TO BE CHECKED IN ORDER TO INVESTIGATE THE PROBLEM. AT FIRST EXAMINATION, THE PUMP DID NOT SHOW THE ERROR 8. THE SM REPLACED THE FOS BOARD (77-1070-002) & THEN, WITH THE PUMP ON, THE ERROR 8 RESUMED. "WE THEN REPLACED THE FEB (77-1010-003), BECAUSE SOMETIMES THIS ERROR IS DUE TO THE MALFUNCTIONING OF THE FEB JUST MENTIONED. WE CHECKED THE PUMP AFTER THE REPLACEMENT OF THE FOLLOWING PARTS: THE FOS BOARD 77-1070-002X, AND THE FEB 77-1010-003 & NO PROBLEMS WERE EVIDENT ANYMORE. WE DID ZERO THE FOS USING THE SIMULATOR WITH SUCCESS A NUMBER OF TIMES." THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE ITALIAN INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK