BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 3739193 · Received March 12, 2014

    Report

    Report Number
    1219856-2014-00059
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    March 2, 2014
    Report Date
    March 2, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL ON (B)(6) 2014 THAT THE RN FROM THE INTENSIVE CARE UNIT (ICU) PHONED THE CLINICAL SUPPORT SPECIALIST (CSS) BECAUSE THE PUMP WAS INTERMITTENTLY NOT PUMPING AND GOING FLAT LINED ON BOTH EKG AND ARTERIAL PRESSURE (AP) WHILE PT WAS STABLE WITH PRESSURES AND HRR (HEART RATE REGULAR). THE CSS FIRST CONFIRMED WITH THE RN IN THE ICU THAT THE PT WAS STABLE AND HAD A PULSE. THE RN THEN RELAYED THAT THE PUMP WAS IN AUTOPILOT, PATTERN TRIGGER AND USING THE TRANSDUCER. THE RN STATED IT WAS A FIBEROPTIX SENSOR (FOS) INTRA-AORTIC BALLOON (IAB). THE ICON WAS BLACK AND THE FOS STATUS WAS SHOWING AE. THE CSS CONFIRMED TWICE WITH THE RN THAT THE FOS STATUS WAS AE AND NOT RE. THE CSS ASKED THE RN TO SEND A STRIP FROM THE PUMP SO THE CSS COULD SEE WHAT WAS HAPPENING. UPON RECEIPT OF THE STRIP, IT HAD NO WAVEFORMS PRESENT AND SHOWED NO PRESSURE; HOWEVER, HAD A HR LISTED OF 88 BPM. THE RN HAD THE PUMP SET TO PRINT A STRIP EVERY 15 MINUTES WITH JUST THE AP WAVEFORM. BEST SIGNAL ANALYSIS IS SHOWING A NOISY SIGNAL. THE CSS CALLED THE RN BACK AND ASKED HER TO TRY CHANGING THE PATCHES AND EXPLAINED THAT THE PUMP WAS NOT SEEING THE EKG CLEARLY ALTHOUGH IT MAY LOOK THAT WAY TO HER. THE CSS ALSO SUGGESTED THAT THE RN ATTEMPT TO CHANGE THE EKG CABLE IF THE PATCH CHANGE DIDN'T HELP. THE CSS EXPLAINED TO THE RN AFTER SEEING THE SECOND STRIP THAT THE IAB IS TIMED APPROPRIATELY AND SEEMINGLY SUPPORTING THE PT WELL. THE CSS DID FURTHER DISCUSS THAT THE EKG IS SHOWING NOISE. THE CSS ASKED THE RN TO CHANGE THE PATCHES AND POSSIBLY THE CABLE. THE CSS TOLD THE RN THAT SHE WOULD CALL HER BACK TO FOLLOW UP IN AN HOUR. AT 1754 CST THE CSS CALLED THE RN BACK AND THE RN SAID THAT IT SEEMED TO BE DOING A LITTLE BETTER, BUT WOULD STILL HAVE PAUSES WHERE THE PUMP WOULDN'T PUMP. THE CSS THEN HAD HER DISCONNECT THE EKG CABLE AND THE PUMP IN AUTOPILOT (CONFIRMED BY THE RN) DID NOT SWITCH TO AP AND ALARMED TRIGGER LOSS. THE RN DID CONFIRM THAT THE PT HAD A PRESSURE. THE CSS THEN ASKED THE RN TO MAKE SURE ALL CABLES WERE CONNECTED AND THE PUMP BEGAN PUMPING AGAIN AND DISPLAYED AN AP WAVEFORM. THE CSS ASKED TH ERN IF SHE HAD CHANGED THE EKG CABLE, BUT TH ERN ONLY CHANGED THE PATCHES AS THE CABLE IS ON THE OTHER PUMP, LOCKED IN THE CATH LAB AND THE RN CANNOT GET TO IT. THE CSS THEN ASKED HER TO SAVE THE IAB-05840-LWS ONCE REMOVED AND ALSO SEND THE PUMP TO BIOMED TO BE CHECKED. THE CSS STATED THAT THE PT WAS GOING TO HAVE OPEN HEART SURGERY (OHS) SOMETIME THIS WEEK. THE CSS ASKED THAT THE RN PUT A NOTE ON THE PUMP NAD CATHETER WITH DIRECTIONS AFTER REMOVAL. THE CSS GAVE TH ERN HER DIRECT CELL NUMBER TO GIVE TO NIGHT SHIFT IF THEY SHOULD HAVE ANY QUESTIONS OVERNIGHT. THE CSS RECEIVED NO FURTHER CALLS. ADDITIONAL INFO RECEIVED ON (B)(4) 2014 FROM THE CHARGE NURSE (CN) STATED THAT THE MALE PT WAS TRANSFERRED TO ANOTHER FACILITY ((B)(6)) ON (B)(6) 2014 FOR SURGERY. THE CN SPOKE WITH THE CATH LAB TECHNICIAN WHO FELT IT WAS A FO INTERMITTENT PROBLEM; IT WAS WORKING, BUT NOT CONTINUOUS. THE PUMP WAS NEVER SWITCHED OUT. THE CN ALSO STATED THEY HAD NO ISSUES AFTER THE PHONE CALL TO THE ARROW HOT LINE AND THE FO WAS WORKING APPROPRIATELY WHEN THE PT WAS TRANSFERRED TODAY. THE CN CALLED THE OTHER FACILITY TO SEE IF THE PT HAD GONE INTO SURGERY YET TRYING TO OBTAIN THE IAB AFTER REMOVAL. THE CN CONNECTED ME WITH THE SURGICAL DEPARTMENT. AFTER BEING PASSED AROUND A FEW TIMES I WAS TOLD THEY DID NOT HAVE A PT ON THEIR SCHEDULE THAT WAS TRANSFERRED FROM ANOTHER FACILITY. UNABLE TO RETRIEVE THE RETURN SAMPLE FROM THE SISTER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149600 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRA-AORTIC BALLOON