BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1203409 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00487
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, BY A CALL PLACED TO HOT LINE AT 0526AM EST, THAT RN STATED THEY HAVE A PATIENT (PT) THAT HAS BEEN HAVING VERY POOR AUGMENTATION. WHEN RN LOOKED AT INTRA-AORTIC BALLOON (IAB) VOLUME ON PUMP, IT SAID 2.5CC & HE WANTED TO KNOW "IF THAT COULD BE WHY". CLINICAL SUPPORT SPECIALIST (CSS) TOLD HIM "DEFINITELY". CSS ASKED RN IF IAB ADAPTER WAS PLUGGED INTO PUMP & IF THEY HAD DISCONNECTED & RECONNECTED IT BEFORE. RN STATED THAT IT WAS "FIRMLY ATTACHED". RN TOLD CSS THAT "THE DOCTORS HAD BEEN IN LAST NIGHT & ATTEMPTED TO CHANGE THE VOLUME: THEY COULD DECREASE BUT NOT INCREASE IT". CSS ASKED RN "HOW LONG IT HAD BEEN THIS WAY" & RN SAID "ALL NIGHT". CSS ASKED RN TO LOOK AT MOUNTED STRIPS TO SEE HOW FAR BACK IT DISPLAYED 2.5CC & RN SAID "AT LEAST SINCE 3PM YESTERDAY AFTERNOON". CSS INFORMED RN THAT "WE COULD NOT ATTEMPT TO CHANGE ADAPTER OR PUMP DUE TO CATHETER BEING IN PT FOR SO LONG WITHOUT BEING INFLATED AT LEAST 2/3'S FULL, & RISK OF CLOT FORMATION COULD CAUSE US TO SHOWER CLOTS FROM IAB IF WE WERE TO FULLY INFLATE IT NOW". CSS RECOMMENDED RN CALL MD & IN THE MEAN TIME, FAX SOME STRIPS TO CSS. WHILE WAITING FOR FAXED STRIPS, CSS PHONED A FIELD SERVICE REP (FSR) TO VERIFY THERE WOULD BE NO POSSIBILITY THAT PUMP COULD ACTUALLY BE PUMPING WITH PROPER VOLUME, EVEN THOUGH ONLY DISPLAYING 2.5CC. FSR AGREED IT WOULD NOT BE LIKELY. PER RN THE CARDIOLOGIST SAID THAT "IF THERE WERE CLOTS THEN THEY WERE ALREADY THERE, SO THEY WOULD CHANGE IT LATER". RN WANTED TO CONFIRM WITH CSS THAT RECOMMENDATION WAS TO REMOVE IAB & CSS TOLD HIM "ABSOLUTELY". CSS ASKED RN TO GET SERIAL NUMBER FROM PUMP & THAT PUMP WOULD NEED TO BE CHECKED PRIOR TO USE ON ANOTHER PATIENT. CSS ASKED RN TO PLEASE REQUEST IAB BE KEPT FOR US TO RETRIEVE. AT 0946 EST, CSS RECEIVED ANOTHER CALL FROM FACILITY & THIS TIM CSS COMMUNICATED TO RN THROUGH SOMEONE ELSE. MD WAS REQUESTING THAT SOMEONE COME IN TO BE THERE WHEN HE REMOVED IAB. CSS EXPLAINED THAT WE DO NOT HAVE PEOPLE IN IMMEDIATE AREA AVAILABLE TO COME IN & SAID THAT SHE WOULD BE GLAD TO ASSIST, HOWEVER SHE COULD VIA PHONE. PERSON ON PHONE STATED THAT THEY WERE REPLACING IAB & ONE OF THE MD'S STATED THAT "THEY WOULD PLACE A DATASCOPE IN BECAUSE ARROW IAB WOULD NOT AUGMENT". CSS APOLOGIZED FOR THEIR DIFFICULTIES & EXPLAINED THE ISSUE WAS SET VOLUME OF HELIUM. "THEY WANTED TO KNOW WHY WE COULD NOT FIX IT & CSS EXPLAINED THAT IF AN IAB IS NOT 2/3 FULL, THERE IS A RISK OF CLOT FORMATION ON IAB. AN IAB THAT IS DORMANT OR UNDER INFLATED FOR LONGER THAN 30 MINUTES NEEDS TO BE REMOVED. CSS ASKED THAT THEY PLEASE RED BAG & KEEP IAB SO THAT WE MAY RETRIEVE IT & THEY AGREED. CSS ALSO SAID THEY SHOULD PULL PUMP TO BE CHECKED BY BIOMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK