BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 6057682 · Received October 26, 2016

    Report

    Report Number
    1219856-2016-00231
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTHING TO RETURN TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2016: ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL BIOMED STATED THAT THE PUMP WAS CHECKED. IT WAS RUN ALL DAY AND OVERNIGHT. HE COULD NOT REPRODUCE THE ISSUES WITH THE PUMP. THE PUMP WAS RETURNED TO SERVICE. IT MAY HAVE BEEN A USER ERROR. NO IAP PARTS OR RECORDER STRIPS WERE RETURNED TO TELEFLEX (B)(4) FACILITY FOR EVALUATION. THE WWS SERVICE DATABASE WAS CHECKED AND THERE WAS NO FURTHER SERVICE PROVIDED TO THE PUMP RELATED TO THE REPORTED COMPLAINT. 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. CONCLUSION: THE REPORTED COMPLAINT OF "BATTERY, HELIUM LOSS, AND PURGE FAILURE ALARM" COULD NOT BE CONFIRMED. THE PUMP WAS CHECKED BY THE HOSPITAL BIOMED AND NO PROBLEMS WERE FOUND WITH THE PUMP. NO PARTS OR RECORDER STRIPS WERE RETURNED TO TELEFLEX (B)(4) FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A HOTLINE CALL. THE (RN) REGISTERED NURSE FROM THE CATH. LAB IS CALLING WITH A PATIENT IN THE (CCU) CARDIAC CARE UNIT THAT CAME FROM THE (OR) OPERATING ROOM. THE PUMP HAD BEEN RUNNING WELL WHEN THEY FIRST ARRIVED FROM THE OR. THEY THEN HAD A COUPLE OF BATTERY ALARMS, WHICH WERE SILENCED, BUT NOT ADDRESSED INITIALLY. THE RN PLUGGED IT IN WHEN SHE ARRIVED. THERE WAS ALSO A "HELIUM" ALARM, AND THAT IS WHEN THE CCU STAFF CALLED THE RN TO THE ROOM. THE RN COULD NOT FIND ANY LEAKS. THE RN ALSO CHANGED THE HELIUM TANK. WHEN THE RN TRIED TO RESUME PUMPING, THE PUMP IMMEDIATELY ALARMED FOR A "LOOSE CONNECTION." THE RN ATTEMPTED TO RESUME PUMPING A COUPLE OF TIMES WITH NO CHANGE. THE RN THEN SWITCHED TO A DIFFERENT PUMP AND THAT PUMP STARTED RIGHT UP WITH NO ISSUES AND CONTINUES TO NOW PUMP WITH NO ISSUES. THERE WAS A DELAY IN THERAPY OF ABOUT 10 MINUTES. THE RN IS CALLING TO REPORT THE ISSUE. THE CLINICAL SUPPORT SPECIALIST FIRST VERIFIED THAT THEY DO HAVE A PUMP RUNNING NOW WITH NO ISSUES. THE CSS WAS ABLE TO FIGURE OUT THE "HELIUM" ALARM WAS A HELIUM LOSS ALARM. THE "LOOSE CONNECTION" WAS A PURGE FAILURE. THE CSS THEN DISCUSSED WITH THE RN THAT THE BATTERY ISSUE WAS SIMPLY THAT IT WAS NOT PLUGGED IN SNUGLY ENOUGH, AND THE RN AGREED WITH THAT. THE CSS AND RN ALSO DISCUSSED THE HELIUM LOSS AND PURGE FAILURE WERE PROBABLY BOTH RELATED TO A CONNECTION ISSUE THAT WAS RESOLVED WHEN THEY CONNECTED TO A DIFFERENT PUMP. THEY ARE GOING TO SEND THE ORIGINAL PUMP TO BIO-MED TO CHECK IT OUT. LENGTH OF TIME PRIOR TO THE EVENT: 6 HOURS ALARMS THAT OCCURRED: HELIUM LOSS, PURGE FAILURE, BATTERY. THE PATIENT IS STABLE ON THE PUMP. THE IAB USED FOR THIS PATIENT WAS (B)(6) S/N (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A HOTLINE CALL. THE (RN) REGISTERED NURSE FROM THE CATH. LAB IS CALLING WITH A PATIENT IN THE (CCU) CARDIAC CARE UNIT THAT CAME FROM THE (OR) OPERATING ROOM. THE PUMP HAD BEEN RUNNING WELL WHEN THEY FIRST ARRIVED FROM THE OR. THEY THEN HAD A COUPLE OF BATTERY ALARMS, WHICH WERE SILENCED, BUT NOT ADDRESSED INITIALLY. THE RN PLUGGED IT IN WHEN SHE ARRIVED. THERE WAS ALSO A "HELIUM" ALARM, AND THAT IS WHEN THE CCU STAFF CALLED THE RN TO THE ROOM. THE RN COULD NOT FIND ANY LEAKS. THE RN ALSO CHANGED THE HELIUM TANK. WHEN THE RN TRIED TO RESUME PUMPING, THE PUMP IMMEDIATELY ALARMED FOR A "LOOSE CONNECTION." THE RN ATTEMPTED TO RESUME PUMPING A COUPLE OF TIMES WITH NO CHANGE. THE RN THEN SWITCHED TO A DIFFERENT PUMP AND THAT PUMP STARTED RIGHT UP WITH NO ISSUES AND CONTINUES TO NOW PUMP WITH NO ISSUES. THERE WAS A DELAY IN THERAPY OF ABOUT 10 MINUTES. THE RN IS CALLING TO REPORT THE ISSUE. THE CLINICAL SUPPORT SPECIALIST FIRST VERIFIED THAT THEY DO HAVE A PUMP RUNNING NOW WITH NO ISSUES. THE CSS WAS ABLE TO FIGURE OUT THE "HELIUM" ALARM WAS A HELIUM LOSS ALARM. THE "LOOSE CONNECTION" WAS A PURGE FAILURE. THE CSS THEN DISCUSSED WITH THE RN THAT THE BATTERY ISSUE WAS SIMPLY THAT IT WAS NOT PLUGGED IN SNUGLY ENOUGH, AND THE RN AGREED WITH THAT. THE CSS AND RN ALSO DISCUSSED THE HELIUM LOSS AND PURGE FAILURE WERE PROBABLY BOTH RELATED TO A CONNECTION ISSUE THAT WAS RESOLVED WHEN THEY CONNECTED TO A DIFFERENT PUMP. THEY ARE GOING TO SEND THE ORIGINAL PUMP TO BIO-MED TO CHECK IT OUT. LENGTH OF TIME PRIOR TO THE EVENT: 6 HOURS ALARMS THAT OCCURRED: HELIUM LOSS, PURGE FAILURE, BATTERY. THE PATIENT IS STABLE ON THE PUMP. THE IAB USED FOR THIS PATIENT WAS IAB-(B)(4) S/N (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708198 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1