BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 7409932 · Received April 9, 2018

    Report

    Report Number
    3010532612-2018-00070
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 12, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). TELEFLEX DID NOT RECEIVE THE DEVICE FOR INVESTIGATION THEREFORE THE REPORTED COMPLAINT OF "FOS SIGNAL LOSS" IS NOT ABLE TO BE CONFIRMED. THE HOSPITAL BIOMED CHECKED THE PUMP AND COULD NOT REPLICATE THE ALARM. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RN THAT AN INTRA-AORTIC BALLOON (IAB) WAS PLACED IN A PATIENT WITH NO ISSUES AND THE FIBER OPTIC SENSOR (FOS) ZERO HAPPENED AS EXPECTED. THE PUMP INITIALLY PUMPED WITH NO PROBLEMS WITH AUTOPILOT USING THE FOS ARTERIAL PRESSURE (AP) SOURCE. AFTER A FEW MINUTES THEY BEGAN TO GET "INSUFFICIENT TIME TO INFLATE" ALARMS AND THE AP WAVEFORM FROM THE FOS IS NOW A FLAT LINE. THE FOS STATUS CODE IS EXCESSIVE OFFSET (EO) WITH A BLUE FOS LIGHTBULB. THEY MANUALLY SWITCHED TO THE TRANSDUCER AP SOURCE, AND THE WAVEFORM IS GOOD. HOWEVER, THE PUMP AUTOMATICALLY SWITCHES BACK TO THE FOS. THE CLINICAL SUPPORT SPECIALIST (CSS) HAD THEM DISCONNECT THE FOS CONNECTOR AND CAL KEY AND THEN RECONNECT WITH NO CHANGE. THEY HAVE ANOTHER PUMP READY TO GO, CSS HAD THEM CONNECT THE FOS TO THE OTHER PUMP. THERE IS A GOOD WAVEFORM FROM THE FOS ON THE SECOND PUMP, CSS HAD THEM SWITCH THE PATIENT TO THE SECOND PUMP. THEY WERE ABLE TO PERFORM THE FOS MAP CAL WITHOUT DIFFICULTY, AND THE PATIENT IS NOW BEING SUPPORTED WELL ON THE SECOND PUMP. CSS RECOMMENDED THAT THEY HAVE THE FOS CONNECTIONS CHECKED ON THE ORIGINAL PUMP. THERE WAS NO PATIENT DEATH, SERIOUS INJURY OR PATIENT COMPLICATION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RN THAT AN INTRA-AORTIC BALLOON (IAB) WAS PLACED IN A PATIENT WITH NO ISSUES AND THE FIBER OPTIC SENSOR (FOS) ZERO HAPPENED AS EXPECTED. THE PUMP INITIALLY PUMPED WITH NO PROBLEMS WITH AUTOPILOT USING THE FOS ARTERIAL PRESSURE (AP) SOURCE. AFTER A FEW MINUTES THEY BEGAN TO GET "INSUFFICIENT TIME TO INFLATE" ALARMS AND THE AP WAVEFORM FROM THE FOS IS NOW A FLAT LINE. THE FOS STATUS CODE IS EXCESSIVE OFFSET (EO) WITH A BLUE FOS LIGHTBULB. THEY MANUALLY SWITCHED TO THE TRANSDUCER AP SOURCE, AND THE WAVEFORM IS GOOD. HOWEVER, THE PUMP AUTOMATICALLY SWITCHES BACK TO THE FOS. THE CLINICAL SUPPORT SPECIALIST (CSS) HAD THEM DISCONNECT THE FOS CONNECTOR AND CAL KEY AND THEN RECONNECT WITH NO CHANGE. THEY HAVE ANOTHER PUMP READY TO GO, CSS HAD THEM CONNECT THE FOS TO THE OTHER PUMP. THERE IS A GOOD WAVEFORM FROM THE FOS ON THE SECOND PUMP, CSS HAD THEM SWITCH THE PATIENT TO THE SECOND PUMP. THEY WERE ABLE TO PERFORM THE FOS MAP CAL WITHOUT DIFFICULTY, AND THE PATIENT IS NOW BEING SUPPORTED WELL ON THE SECOND PUMP. CSS RECOMMENDED THAT THEY HAVE THE FOS CONNECTIONS CHECKED ON THE ORIGINAL PUMP. THERE WAS NO PATIENT DEATH, SERIOUS INJURY OR PATIENT COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251354 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1