BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2195037 · Received July 20, 2011

    Report

    Report Number
    1219856-2011-00266
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 19, 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
    ME, 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 VIA CALL REPORT FROM THE RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED POST ARREST IN THE CATH LAB. THE FIBEROPTIX (FOS) CABLE BECAME ENTANGLED DURING INSERTION, BUT CONNECTED AND PROPERLY ZEROED PRIOR TO INSERTION WITH A GOOD ARTERIAL PRESSURE (AP) WAVEFORM. AFTER ARRIVAL TO THE CARDIAC INTENSIVE CARE UNIT IN ORDER TO HAVE ENOUGH CABLE TO POSITION THE PUMP, THEY REMOVED THE FOS SLIDE AND CAL KEY, UNTANGLED THE LINE AND RECONNECTED IT TO THE PUMP. AFTER THE RECONNECTION, THE LIGHT BULB WAS BLACK, NO AUDIBLE TONES WERE NOTED AND NO FOS AP WAVEFORM PRESENT. THIS RECONNECTION WAS ATTEMPTED SEVERAL TIMES WITH NO CHANGE. THE RADIAL AP WAVEFORM WAS USED AS THE SOURCE FOR THE PUMP. SHORTLY AFTER THE DISPLAY SCREEN WENT "WHITE AND OR BLACK" THEY ATTEMPTED TO DISCONNECT AND RECONNECT THE UMBILICAL CABLE, WITH NO CHANGE, SO THE PUMP WAS EXCHANGED FOR A SECOND PUMP ((B)(4)). THE PUMP HAD CONTINUED TO PUMP SO THERAPY WAS NOT INTERRUPTED. THE PUMP THAT WAS REMOVED IS CURRENTLY IN CLINICAL ENGINEERING FOR EXAMINATION. THE CSS HAD THE RN CHECK THE FOS STATUS ON THE SECOND PUMP. THE LIGHT BULB IS CURRENTLY BLACK, THE FOS STATUS CODES ARE LL (LOW LIGHT), CK (CAL KEY MISSING), RE (RATIOMETRIC ERROR), PL (OUTSIDE PRESSURE LIMIT). THE RN ATTEMPTED DISCONNECT AND RECONNECT AGAIN WITH NO CHANGE OR AUDIBLE TONES. THE RADIAL AP SOURCES WAS IN USE AND THE PUMP WAS ACHIEVING THE GOALS OF THERAPY. THE RN HAS FLAGGED THIS IABP FOR RETURN TO THE COMPANY WHEN REMOVED FROM THE PT. THE CSS REVIEWED TROUBLESHOOTING METHODS FOR THE FOS AND UMBILICAL CABLE CONNECTION WITH THE RN.

    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 INTRA-AORTIC BALLOON