BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 3002089 · Received February 12, 2013

    Report

    Report Number
    1219856-2013-00029
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ARROW INTERNATIONAL, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS/ACTION TAKEN: CHECKED TRIGGERING WITH SIMULATOR. FOUND DISPLAY CABLE PULLED OUT AND NOT MAKING GOOD CONTACT INSIDE HELIUM COMPARTMENT. REPLACED CABLE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 FROM THE SALES REP WHO SPOKE WITH THE HOSPITAL. AS A RESULT, THE PUMP (SERIAL NUMBER (B)(4)) WAS REPLACED WITH ANOTHER IABP (AUTOCAT2 WAVEFORM, SERIAL NUMBER (B)(4)) SUCCESSFULLY. THERE WAS AN APPROX 2 - 3 MINUTE DELAY OR INTERRUPTION IN THERAPY, JUST LONG ENOUGH TO EXCHANGE THE IABP WITH NO HARM TO THE PT. THE IABP THERAPY HAD CONTINUED SUCCESSFULLY UNTIL OTHER DIFFICULTIES WERE ENCOUNTERED WITH THE SECOND PUMP. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS, OR INJURY AT THIS TIME. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PT WAS ON LIFE SUPPORT. REF MDR# 1219856-2013-00030 FOR THE SECOND PUMP REPORT INVOLVING THE SAME PT. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL FROM THE CATH LAB RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) AT 1650 MST THAT THEY NEEDED SOMEONE TO COME AND CHECK OUT TWO OF THEIR INTRA-AORTIC BALLOON PUMPS (IABP) THAT WERE DOWN. THE RN IS ALSO INQUIRING ABOUT A RENTAL PUMP. THE CSS TOLD THE RN THAT IT WOULD PROBABLY BE NEXT WEEK BEFORE SOMEONE FROM FIELD SERVICE COULD BE THERE. THE CSS ALSO TOLD THE RN THAT THE FIELD SERVICE REP (FSR) WOULD GIVE THE RN A CALL ABOUT THIS AND THE RENTAL PUMP. THE RN THANKED THE CSS FOR THE CALL. THE CSS THEN CALLED THE FSR AND GAVE THE CONTACT INFORMATION OF THE RN. THE FSR STATED CALLING THE RN BACK TO DISCUSS THE PUMPS. AT 1843 MST, THE CSS SPOKE WITH THE FSR AGAIN. THE FSR HAD SPOKEN WITH THE RN AND THE SALES REP AND EVERYTHING IS SET FOR THEM TO GET A PUMP. THE FSR CALLED THE CSS BACK TO LET IT BE KNOWN THAT IT WAS BEING TAKEN CARE OF. PER THE FILED SERVICE REPORT RECEIVED ON (B)(4) 2013: INTERMITTENT TRIGGERING PROBLEMS. PUMP WAS ON PT. DISPLAY WOULD SOMETIMES TURN WHITE. UNCONFIRMED. SOFTWARE LEVEL 2.24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62169 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON