BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 4070971 · Received August 29, 2014

    Report

    Report Number
    1219856-2014-00160
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE/PARTS WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RN CALLED THE CLINICAL SUPPORT SPECIALIST (CSS) CONCERNING A PATIENT THAT RECENTLY HAD AN INTRA-AORTIC BALLOON (IAB) PLACED IN THE CATH LAB ABOUT 8 HOURS AGO. THEY ARE PLANNING ON DOING OHS (OPEN HEART SURGERY) WITH THIS PATIENT IN THE NEXT COUPLE OF DAYS. THE RN STATED THAT JUST BEFORE SHE CAME ON THE NURSE FROM THE DAY SHIFT HAD REPORTED THAT THE PUMP HAD ALARMED FOR HELIUM LOSS SEVERAL TIMES. THE RN REPORTED THAT IT HAS CONTINUED TO DO SO. THE RN THEN SAID THAT THEY HAVE ALREADY SWITCHED THIS PUMP OUT FOR ANOTHER ONE AND THERE HAVE BEEN NO ALARMS SINCE THEN. THE CSS HAD THE RN CLARIFY HOW OFTEN THE ALARM WAS HAPPENING AND THE RN STATED THAT IT WOULD ALARM SPORADICALLY ABOUT EVERY 30-40 MINUTES OR SO. THERE HAVE BEEN NO ALARMS SINCE THEY SWITCHED TO A DIFFERENT PUMP. THERE HAVE BEEN NO ALARMS SINCE THEY SWITCHED TO A DIFFERENT PUMP. THERE WAS A DELAY IN THERAPY OF ABOUT 5 MINUTES TO SWITCH THE PUMPS OUT. THE CSS AND RN HAD A DISCUSSION ABOUT HELIUM LOSS ALARMS. THE CSS DISCUSSED WHAT CAN CAUSE THEM. THE RN DOES NOT RECALL WHAT THE BPW (BALLOON PRESSURE WAVEFORM) LOOKED LIKE WHEN THE ALARMS HAPPENED AND SHE DIDN'T KEEP ANY STRIPS TO ANALYZE. THE CSS RECOMMENDED THAT THE NEXT TIME THERE IS AN ALARM THAT THEY SHOULD KEEP THE STRIPS. THE RN IS GOING TO SEND THE PUMP TO BIO-MED TO BE CHECKED OUT. THE CSS RECEIVED NO FURTHER CALLS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 STATED THE RN IN THE INTENSIVE CARE UNIT CALLED THE CSS BECAUSE THE FIBEROPTIX SENSOR (FOS) PRESSURE HAVE BEEN MUCH LOWER THAN THE PRESSURES FROM THE CENTRAL LUMEN. THEY SWITCHED OVER TO THE TRANSDUCER TO ET THE PRESSURE READINGS AND THE PUMP AUTOMATICALLY SWITCHED BACK TO FOS. THE RN WAS WONDERING IF THEY COULD DISCONNECT THE FOS. THE CSS FIRST VERIFIED THAT THE PUMP IS RUNNING WELL AND IS PROVIDING GOOD SUPPORT. THE CSS THEN ASCERTAINED THAT THIS IS THE SAME PATIENT THAT A CALL CAME IN OVER THE HOTLINE YESTERDAY AND THEY HAD SWITCHED THE PUMP OUT FOR THE ONE CURRENTLY RUNNING WHEN THEY HAD SWITCHED THE PUMPS, THE FOS WAS NEVER CALIBRATED FOR THE CURRENT PUMP. THE CSS EXPLAINED TO THE RN THAT IS WHY THE PRESSURE ON THE FOS ARE NOT ACCURATE. THE CSS WALKED THE RN THROUGH AN FOS MAP CAL AND NOW THE PRESSURES ON THE FOS ARE NOT ACCURATE. THE CSS WALKED THE RN THROUGH AN FOS MAP CAL AND NOW THE PRESSURES ARE MUCH CLOSER TO THE CENTRAL LUMEN PRESSURES. THE FOS LIGHT BULB ICON IS NOW WHITE (FOS LAB CAL VALUE MANUALLY ADJUSTED) AND FOS STATUS CODE IS OK. IT WAS REPORTED THAT THE PATIENT OUTCOME IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527963 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1