BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE ITALIAN

    MDR report key: 5166316 · Received October 21, 2015

    Report

    Report Number
    1219856-2015-00214
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 28, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). DEVICE EVALUATION: THE FOS (FIBEROPTIX SENSOR) BOARD WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE FOS BOARD WAS PERFORMED AND NO OBVIOUS DAMAGE OR DEFECT WAS FOUND. THE FOS BOARD IN QUESTION WAS INSTALLED ONTO THE CPU/FE/FOS BOARD TEST FIXTURE AND THE TEST WAS PERFORMED. NO FAULTS WERE FOUND WITH THE FOS BOARD IN QUESTION. THE FOS BOARD PASSED THE FUNCTIONAL TEST. THE FOS BOARD WAS INSTALLED INTO A KNOWN GOOD INTRA-AORTIC BALLOON PUMP (AUTOCAT2W) AND PERFORMED THE FUNCTIONAL TESTING USING THE FOS TESTER. THE FOS WAS PROPERLY ZEROED (STATUS O.K). THE FOS BOARD WAS THEN TESTED WITH FOS TESTER, DIGITAL MANOMETER AND TYCOS GAGE TO DETERMINE IF THE FOS SENSOR WOULD COMMUNICATE AND DISPLAY THE PROPER PRESSURE READINGS ON THE IABP DISPLAY WHEN IN USE. THE SENSOR WAS SUBJECTED TO MULTIPLE PRESSURES (0, 50, 100, 150, 200, 250 AND 300 MMHG). WHEN THE READINGS ON THE DIGITAL MANOMETER WERE COMPARED TO THE IABP DISPLAY READINGS THEY WERE WITHIN TOLERANCE. BEFORE, DURING AND AFTER TESTING PROPER STATUS CODES WERE VERIFIED ON THE IABP DISPLAY HEAD. THE IABP WAS LEFT TO RUN FOR SIX HOURS WITHOUT ANY ALARMS OR ERRORS. THE FOS BOARD FUNCTIONED AS INTENDED. SEE OTHER REMARKS SECTION. OTHER REMARKS: A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF "ALARM, SYSTEM ERROR 8" WAS CONFIRMED BY TELEFLEX (B)(4); HOWEVER, THE REPORT PROBLEM COULD NOT BE REPRODUCED AT TELEFLEX (B)(4) FACILITY DURING THE FUNCTIONAL TEST. THE FOS BOARD PASSED FUNCTIONAL TESTING. THE CAUSE OF THE REPORT COMPLAINT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EXPEDITED QUALITY REVIEW REPORT: PUMP WAS ON PATIENT. SYMPTOM - FOS (FIBEROPTIX SENSOR) "ERROR 8" REPORTED BY THE CUSTOMER. THE INTRA-AORTIC BALLOON PUMP (IABP) HAD BEEN SWITCHED OUT TO ANOTHER IABP. THE CUSTOMER DID NOT REPORT ANY FURTHER COMPLICATIONS FOR THE PATIENT. ACTIONS: FOS BOARD NEED TO BE REPLACED IN ORDER TO HAVE FOS AP (ARTERIAL PRESSURE) READING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EXPEDITED QUALITY REVIEW REPORT: PUMP WAS ON PATIENT. SYMPTOM - FOS (FIBEROPTIX SENSOR) "ERROR 8" REPORTED BY THE CUSTOMER. THE INTRA-AORTIC BALLOON PUMP (IABP) HAD BEEN SWITCHED OUT TO ANOTHER IABP. THE CUSTOMER DID NOT REPORT ANY FURTHER COMPLICATIONS FOR THE PATIENT. ACTIONS: FOS BOARD NEED TO BE REPLACED IN ORDER TO HAVE FOS AP (ARTERIAL PRESSURE) READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694536 AUTOCAT2 WAVE ITALIAN INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1