BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 14986848 · Received July 12, 2022

    Report

    Report Number
    3010532612-2022-00245
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 15, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051715
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF PERSISTENT PURGE FAILURE ALARMS IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE REPORTED COMPLAINT OF PERSISTENT PURGE FAILURE ALARMS WAS CONFIRMED BY THE FIELD SERVICE AGENT. NO PART WAS RETURNED FOR INVESTIGATION. ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER CHOSE NOT TO HAVE SERVICE PERFORMED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE PURGE FAILURE ALARM. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT "A 40CC LWS WAS PLACED WITHOUT DIFFICULTY. THE STAFF HAVE TRIED TO START THE PUMP WITHOUT SUCCESS. THE PUMP IMMEDIATELY ALARMS WITH A "PURGE FAILURE" ALARM. STAFF STATED THAT THEY DO HAVE A GOOD AP WAVEFORM PRESENT FROM THE FOS, HOWEVER IT HAS NOT BEEN ZEROED. THE EKG WAS PLACED ON THE PATIENT, AND THERE IS A GOOD EKG SIGNAL ON THE PUMP AS WELL. IT WAS CONFIRMED THAT THERE IS HELIUM IN THE TANK, AND IT IS ALMOST FULL. THE GAS CONNECTOR IS CORRECTLY CONNECTED. THE STAFF START THE PUMP AGAIN, BUT IT STILL IMMEDIATELY ALARMED FOR "PURGE FAILURE". AS A RESULT, THE STAFF SWAPPED OUT THE PUMP AND PERFORMED FOS MAP CALIBRATION. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE PATIENT WAS BEING WELL SUPPORTED BY THE SECOND PUMP WITH NO FURTHER ISSUES".

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT "A 40CC LWS WAS PLACED WITHOUT DIFFICULTY. THE STAFF HAVE TRIED TO START THE PUMP WITHOUT SUCCESS. THE PUMP IMMEDIATELY ALARMS WITH A "PURGE FAILURE" ALARM. STAFF STATED THAT THEY DO HAVE A GOOD AP WAVEFORM PRESENT FROM THE FOS, HOWEVER IT HAS NOT BEEN ZEROED. THE EKG WAS PLACED ON THE PATIENT, AND THERE IS A GOOD EKG SIGNAL ON THE PUMP AS WELL. IT WAS CONFIRMED THAT THERE IS HELIUM IN THE TANK, AND IT IS ALMOST FULL. THE GAS CONNECTOR IS CORRECTLY CONNECTED. THE STAFF START THE PUMP AGAIN, BUT IT STILL IMMEDIATELY ALARMED FOR "PURGE FAILURE". AS A RESULT, THE STAFF SWAPPED OUT THE PUMP AND PERFORMED FOS MAP CALIBRATION. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE PATIENT WAS BEING WELL SUPPORTED BY THE SECOND PUMP WITH NO FURTHER ISSUES".

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT "A 40CC LWS WAS PLACED WITHOUT DIFFICULTY. THE STAFF HAVE TRIED TO START THE PUMP WITHOUT SUCCESS. THE PUMP IMMEDIATELY ALARMS WITH A "PURGE FAILURE" ALARM. STAFF STATED THAT THEY DO HAVE A GOOD AP WAVEFORM PRESENT FROM THE FOS, HOWEVER IT HAS NOT BEEN ZEROED. THE EKG WAS PLACED ON THE PATIENT, AND THERE IS A GOOD EKG SIGNAL ON THE PUMP AS WELL. IT WAS CONFIRMED THAT THERE IS HELIUM IN THE TANK, AND IT IS ALMOST FULL. THE GAS CONNECTOR IS CORRECTLY CONNECTED. THE STAFF START THE PUMP AGAIN, BUT IT STILL IMMEDIATELY ALARMED FOR "PURGE FAILURE". AS A RESULT, THE STAFF SWAPPED OUT THE PUMP AND PERFORMED FOS MAP CALIBRATION. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE PATIENT WAS BEING WELL SUPPORTED BY THE SECOND PUMP WITH NO FURTHER ISSUES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772322 AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000320 N/A 30801902051715

    Patients

    Seq Age Sex Outcome Treatment
    1 Male NONE REPORTED.| NONE REPORTED.| NONE REPORTED.