BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 6360866 · Received February 27, 2017

    Report

    Report Number
    1219856-2017-00038
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 1, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PARTS WERE DISCARDED.

    Additional Manufacturer Narrative · 1

    TELEFLEX DID NOT RECEIVE THE DEVICE FOR ANALYSIS. THE REPORTED COMPLAINT OF "FOS NOT RECOGNIZED" WAS CONFIRMED BY THE FIELD SERVICE ENGINEER. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IAP SERIAL AND LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX WILL CONTINUE TO CLOSELY MONITOR.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: (B)(4). SYMPTOM: OP-ON PATIENT. FOS IS NOT WORKING. FINDINGS/ACTION TAKEN: PERFORM FUNCTIONAL CHECK - CONFIRMED FIBER OPTIC SENSOR (FOS) NOT WORKING. FOUND AND REPLACED DEFECTIVE FOS PRINT CIRCUIT BOARD (PCB) AND OLD FOS CONNECTOR. FOS NOW - CHECKS OK. FCN LEVEL: 1416. SOFTWARE LEVEL: 2.24. PER THE FIELD SERVICE ENGINEER, ON TUESDAY (B)(6) 2017 THE PUMP WAS NOT RECOGNIZING WHEN A FOS BALLOON WAS INSERTED. THEY JUST SWAPPED THE PUMP WITH ANOTHER ONE AND CONTINUED AS NORMAL. NO PATIENT COMPLICATIONS. THE FIELD SERVICE ENGINEER (FSE) REPLACED A DEFECTIVE FOS PCB TO REPAIR THE PROBLEM. THE BOARD WAS ONE OF THE OLD STYLE BOARDS. THE FOS SLIDER WAS OLD SO HE REPLACED THAT AS WELL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA A FIELD SERVICE REPORT: L612131. SYMPTOM: OP-ON PATIENT. FOS IS NOT WORKING. FINDINGS/ACTION TAKEN: PERFORM FUNCTIONAL CHECK - CONFIRMED FIBER OPTIC SENSOR (FOS) NOT WORKING. FOUND AND REPLACED DEFECTIVE FOS PRINT CIRCUIT BOARD (PCB) AND OLD FOS CONNECTOR. FOS NOW - CHECKS OK. FCN LEVEL: 1416. SOFTWARE LEVEL: 2.24. PER THE FIELD SERVICE ENGINEER, ON TUESDAY (B)(6) 2017 THE PUMP WAS NOT RECOGNIZING WHEN A FOS BALLOON WAS INSERTED. THEY JUST SWAPPED THE PUMP WITH ANOTHER ONE AND CONTINUED AS NORMAL. NO PATIENT COMPLICATIONS. THE FIELD SERVICE ENGINEER (FSE) REPLACED A DEFECTIVE FOS PCB TO REPAIR THE PROBLEM. THE BOARD WAS ONE OF THE OLD STYLE BOARDS. THE FOS SLIDER WAS OLD SO HE REPLACED THAT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145416 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1