BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2150555 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00209
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO RECEIVED PER FIELD SVC REPORT: SYMPTOM - PER SALES REP THE PUMP STOPPED PUMPING - KEYPAD UNRESPONSIVE, NO ALARM. FINDINGS/ACTION TAKEN: THE BIOMED TECH WAS UNABLE TO DUPLICATE PROBLEM. HE CHECKED CONNECTION INSIDE THE PUMP AND CIRCUIT BOARDS. RAN PUMP FOR 1.5 DAYS. UNIT BACK IN SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RN CALLED BECAUSE THE "CHAIR LOOKS WEIRD." THE RN STATED THAT THEY HAD ONE HELIUM LOSS 2 ALARM EARLIER IN THE SHIFT, BUT NO MORE SINCE THEN. THERE WAS NO BLOOD PRESENT IN THE DRIVELINE. THE RN FELT THE PUMP WAS PUMPING WELL CONSIDERING THE RHYTHM, BUT WANTED TO KNOW WHY THE BPW (BALLOON PRESSURE WAVEFORM) IS SO THIN. PT IS IN AUTOPILOT MODE, 1:1, PEAK TRIGGER, ARRHYTHMIA DETECTED (PT IN BIGEMINY RATE 100 BPM WITH FREQUENT PVCS). TIMING METHOD IN USE IS WAVE/PREDICTIVE WITH A GREEN FIBEROPTIX SENSOR (FOS) LIGHT BULB AND FOS OK STATUS CODES. THE CLINICAL SUPPORT SPECIALIST (CSS) HAD THE RN FAX A STRIP OF THE BPW, THE RN ALSO HAS THE STRIP FROM THE EARLIER ALARM. THE CSS EXPLAINED THAT BASED ON THE STRIP, SEVERAL ISSUES ARE CAUSING THE SKINNY BPW AND POSSIBLE THE LOSS ALARM THAT OCCURRED EARLIER. THERE IS OBVIOUS SLOPPING OF THE BPW ON INFLATION AND DEFLATION (MUCH MORE PROMINENT WHEN THE ALARM OCCURRED). THIS IN AN INDICATION OF SLOW GAS AND A PARTIAL OBSTRUCTION. THE CSS REVIEWED TROUBLESHOOTING AND PT POSITIONING TECHNIQUES WHICH THE RN FEELS ARE AS GOOD AS OBTAINABLE. THE CSS EXPLAINED THAT THE SLOW GAS IS ALSO POTENTIALLY THE REASON WHY THE PUMP IS STAYING IN PEAK TRIGGER INSTEAD OF SWITCHING INTO AFIB, AS WELL AS DEFLATING EARLY SINCE IT IS USING PEAK WHICH ALSO NARROWS THE WAVEFORM. THE PT IS (B)(6) WITH A 40 CC IAB IN USE ((B)(4)). THE CSS EXPLAINED THAT WE CAN REDUCE VOLUME TO ASSIST THE GAS SPEED, BUT FIRST WE TRIED TO USE THE R WAVE DEFLATION ON SETTING. AFTER DOING SO, THE RN FELT THE WAVEFORMS (TIMING AND BPW) WERE BOTH SIGNIFICANTLY BETTER. THE CSS REVIEWED WITH THE RN HOW TO WATCH FOR LATE DEFLATION AND IF IT OCCURS WE COULD DECREASE VOLUME TO ASSIST OR TURN THE R WAVE OFF AND ALLOW THE PUMP TO GO BACK TO PEAK TRIGGER. EITHER WAY, THERE WOULD BE ADD'L OPTIONS SHOULD THE PT'S STATUS CHANGE AND THE RN SHOULD CALL THE CSS DIRECTLY IF THAT WERE TO HAPPEN. THE RN FELT THAT THINGS WERE GREATLY IMPROVED AT THIS TIME. ON 0312 EST THE NURSE CALLED BACK AND SAID THAT THINGS HAD BEEN GREAT AND THEN THE PUMP SUDDENLY "FROZE, STOPPED PUMPING AND WOULD NOT ALLOW HER TO CHANGE ANY SETTINGS." THE RN STATED THAT NO ALARM HAD OCCURRED. THEY ALREADY HAD ANOTHER PUMP IN PLACE AND WANTED THE CSS TO WALK THEM THROUGH THE EXCHANGE. THE PUMPS WERE EXCHANGED WITHOUT INCIDENT AND A MANUAL CALIBRATION WAS PERFORMED ON THE FOS. THE RN STATED SHE WOULD SEND THE PUMP TO BIOMED TO BE CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. KC8081172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK