BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1143723 · Received August 29, 2008

    Report

    Report Number
    1219856-2008-00419
    Event Type
    Death
    Date Received
    August 29, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HOT LINE CALL RECEIVED BY CLINICAL SUPPORT SPECIALIST (CSS), THAT THE PERFUSIONIST STATED THEY HAD A PATIENT (PT.) ON INTRA-AORTIC BALLOON PUMP (IABP) IN CATH LAB, AND THEY WERE DISCONNECTING TO GO TO OPERATING ROOM. PT. WAS CODING, SLAVE CABLE WAS DISCONNECTED, AND HE LOST FIBEROPTIX SENSOR (FOS) ARTERIAL PRESSURE (AP). HE STATED AP SOURCE WAS STILL HIGHLIGHTED UNDER FOS. HE REINSERTED SLAVE CABLE AND GOT AN AP WAVEFORM WHILE THE SOURCE REMAINED HIGHLIGHTED IN FOS. WHEN REMOVING SLAVE CABLE, HE LOST AP WAVEFORM AGAIN AND IT REMAINED HIGHLIGHTED IN FOS. DURING TIME IABP WAS IN USE, PT. WAS IN AND OUT OF HAVING A PULSE. CCS ASKED IF PUMPING STOPPED WHEN AP WAVEFORM WAS GONE; HE STATED PUMP DID STOP PUMPING. CSS ALSO CONFIRMED THAT PERFUSIONIST WAS SURE SOURCE REMAINED HIGHLIGHTED ON FOS WHEN AP WAVEFORM DISPLAYED (WHEN SLAVE CABLE WAS REINSTATED) AND HE STATED HE THOUGHT SO, BUT WASN'T 100% SURE. CSS STATED PUMP IS DESIGNED TO HIGHLIGHT AP SOURCE, AND AP SOURCE WILL CHANGE AUTOMATICALLY IN AUTOPILOT. PUMP SHOULD NOT REMAIN HIGHLIGHTING FOS FOR AP IF IT IS USING ANOTHER SOURCE, SUCH AS A SLAVE SIGNAL FROM MONITOR. WHILE ON THE PHONE PERFUSIONIST STATED THAT PT. HAD SINCE EXPIRED. CSS ASKED IF IT WAS POSSIBLE THAT COMPRESSIONS STOPPED AT THE TIME THAT THEY HAD REMOVED SLAVE CABLE AND/OR, IF CHANGE OF SOURCE COULD HAVE COME FROM HAVING LOW FLOW STATE WHILE CHECKING FOR PULSE AND THEN HIGH FLOW DUE TO COMPRESSIONS. HE STATED IT COULD BE POSSIBLE. CSS ALSO MENTIONED THAT AP HAS AUTO GAIN FOR SIZE OF AP WAVEFORM AND MAYBE THAT ALSO CONTRIBUTED TO CONFUSING SITUATION DURING COMPRESSION AND CHECKING FOR PULSE.

    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 Death