BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1203523 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00482
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 9, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED, IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH 1219856-2008-00485 FOR FIRST EVENT INVOLVING SAME PATIENT AND INTRA-AORTIC BALLOON. IT WAS REPORTED BY A CALL PLACE TO THE HOT LINE, THAT THERE WAS BLOOD IN THE DRIVE LINE AND PUMP WAS STILL PUMPING. REGISTERED NURSE (RN) CURRENTLY HAD PUMP OFF AND WANTED TO KNOW WHAT COULD BE WRONG WITH IT. INTRA-AORTIC BALLOON (IAB) WAS PLACED IN 2008. RN STATED THAT THERE WAS A LOT OF BLOOD COMING BACK IN DRIVE LINE. CLINICAL SUPPORT SPECIALIST (CSS) ASKED IF HE HAD ANY ALARMS AND HE STATED THERE WERE NO ALARMS AND PUMP WAS PUMPING IN AUTOPILOT. CSS EXPLAINED THERE COULD BE A CENTRAL LUMEN FRACTURE SINCE THIS OCCURRED WHILE THEY WERE PREPPING THE PATIENT. BALLOON COULD STILL BE INTACT, BUT CENTRAL LINE FRACTURE WOULD ALLOW BLOOD TO ENTER HELIUM LINE. CSS STATED THAT THEY NEEDED TO REPLACE THE BALLOON CATHETER. RN UNDERSTOOD THIS AND SAID THEY WERE GOING TO DO THAT NOW. CSS ASKED THE RN TO SAVE THE BALLOON. RN DID NOT HAVE TIME TO GIVE CSS THE SN FROM PUMP OR BALLOON.

    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 UNKNOWN INTRA-AORTIC BALLOON (ARROW)