BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE

    MDR report key: 2427245 · Received January 5, 2012

    Report

    Report Number
    1219856-2011-00489
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K0160309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST TIME THE PERFUSIONIST CALLED THE HOT LINE, IT WAS TO ASK THE CLINICAL SUPPORT SPECIALIST (CSS) HOW TO CONNECT A DATASCOPE (DS) CATHETER TO AN ARROW IAP-0500. WHEN THE PT (PT) ARRIVED AT THE FACILITY, THE PERFUSIONIST MADE THE CONNECTION TO THE IAP-0500. AT THIS TIME, THE PUMP ALARMED "HE LOSS." THE PT IS "QUITE HEAVY" WITH A DS CATHETER INSERTED INTO HIS RIGHT FEMORAL ARTERY; PT IS STABLE, SINUS TACH. THE PERFUSIONIST TOLD THE CSS THAT "THERE WERE NO ALARMS ON DS PUMP." THE CSS EXPLAINED TO THE PERFUSIONIST THE DIFFERENCE IN THE OPERATING SYSTEMS AND WHY THIS MAY OCCUR. THE CSS INSTRUCTED THE PERFUSIONIST TO PUMP AT 1:2 AND DECREASE THE VOLUME TO 35 CC, HOWEVER, THE "HE LOSS" ALARM CONTINUED. THE CSS SUGGESTED THAT THE PERFUSIONIST NOTIFY THE MD. THE CSS TOLD THE PERFUSIONIST "WE CAN ATTEMPT TO DECREASE THE VOLUME UP TO A THIRD OF THE FULL VOLUME; HOWEVER, WE ARE ALREADY DECREASING THE EFFECTIVENESS AT THE CURRENT SETTINGS." AN ATTEMPT WAS MADE TO DO A LEAK TEST ON THE CATHETER, HOWEVER, THE LEAK ALARM CONTINUED. THE PERFUSIONIST STATED "THERE APPEARED TO BE A LOT OF EXTENSION TUBING CONNECTED TO THE CATHETER AND WANTED TO KNOW IF THAT COULD BE THE ISSUE." THE CSS TOLD THE PERFUSIONIST THAT SHE "COULD NOT ADVISED HIM ON REMOVING ANY TUBING FROM THE "MAQUET" (DS) CATHETER SINCE IT'S NOT MY PRODUCT AND I DON'T KNOW THEIR RECOMMENDATION." THE CSS SUGGESTED THAT THE PERFUSIONIST CALL THE MAQUET HOT LINE REGARDING THE CATHETER. THE CSS STATED "INCREASED TUBING WILL SLOW DOWN GAS TO AND FROM THE CATHETER WHICH COULD RESULT IN LEAK ALARMS." IN THE MEAN TIME, THE CSS ASKED THE PERFUSIONIST TO FAX A STRIP. THE STRIP SHOWS VERY SLOW RETURN OF GAS TO THE PUMP WHICH COULD BE RESULTING IN THE LEAK ALARM OR COULD BE KINK RELATED AS WELL. THE CSS SUGGESTED THEY VERIFY INTRA-AORTIC BALLOON (IAB) PLACEMENT. CARDIOLOGY CAME IN AND REPOSITIONED THE CATHETER BASED ON THE CXR (CHEST X-RAY) THEY OBTAINED, HOWEVER, THE ALARMS CONTINUED. THE MD FEELS THIS IS RELATED TO THE PT'S SIZE AND ANGLE OF INSERTION AND STATED HE WOULD PROBABLY REMOVE THE CATHETER IN THE MORNING. THE CSS REVIEWED THE POTENTIAL RISKS ASSOCIATED WITH CONTINUING TO PUMP WITH LEAK ALARMS; THE PERFUSIONIST UNDERSTOOD AND REVIEWED THE RISKS WITH THE MD. THE PT IS STABLE. THE CSS "STRONGLY RECOMMENDED THEY CONTACT MAQUET REGARDING THE EXTENSION TUBING CONNECTED TO THE CATHETER FOR THEIR RECOMMENDATION." THE PERFUSIONIST STATED "HE HAD ALSO EXCHANGED CONSOLES WITH NO CHANGE IN ALARMS." THE CSS SPOKE WITH THE PERFUSIONIST EIGHT TIMES, WITH THE LAST CONVERSATION AT 2300. THE PERFUSIONIST STATED "THE MD HAD DECIDED TO CONTINUE AS THEY WERE AND RE-CHECK IN THE AM." THE CSS REMINDED THE PERFUSIONIST "TO STRESS TO NURSING THAT THEY CONSTANTLY CHECK THE TUBING FOR BLOOD." THE CSS FOLLOWED UP WITH THE PERFUSIONIST AT 1031 EST. THE PERFUSIONIST STATED "THE MD CHOSE TO REMOVE THE CATHETER. THEY HAVE NOT INSERTED A REPLACEMENT. THE PT IS CURRENTLY STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAQUET INTRA-AORTIC BALLOON CATHETER.