BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROAUTOCAT 2 WAVE

    MDR report key: 3001036 · Received February 27, 2013

    Report

    Report Number
    1219856-2013-00048
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL REPORT AT 0028 CST THAT THE RN CALLED DUE TO RECEIVING PURGE FAILURE ALARMS ON THE TRANSPORT PUMP WHEN PUMPING INITIATED. WHEN THE RN ATTEMPTED TO CONNECT THE PATIENT FROM THE HOSPITAL'S PUMP TO HER TRANSPORT PUMP, SHE RECEIVED A PURGE FAILURE ALARM IMMEDIATELY AND THE PUMP WOULD NOT PUMP. BOTH TIMES, SHE PLACED THE PATIENT BACK ON TO THE HOSPITAL'S PUMP AND BEGAN PUMPING AGAIN WITHOUT ISSUE. THE RN CONFIRMED THAT THERE ARE NO KINDS IN THE LINE AND THE HOSPITAL'S PUMP WORKS WITHOUT ISSUE. THEY ARE IN THE PROCESS OF TRANSPORTING THE PATIENT FROM THE CLINIC BACK TO THE HOSPITAL. THIS IS A FIXED WING TRANSPORT AT APPROXIMATELY 90 MINUTES WHEELS UP/WHEELS DOWN. THE CLINICAL SUPPORT SPECIALIST (CSS) HAD THE RN ATTEMPT THIS AGAIN. THE RN CONFIRMED THAT SHE HAS A STABLE EKG TRACING ON HER PUMP, THERE WAS 415 PSI IN THE HELIUM TANK AND THE TANK VALVE WAS OPEN TO THE PUMP AND CONNECTED THE GAS LINE. IT RECOGNIZED THE 40CC INTRA-AORTIC BALLOON (IAB) AT B.VOL ON THE MONITOR. WHEN THE RN PRESSED THE PUMP ON (GREEN) BUTTON, THE PURGE FAILURE ALARM OCCURRED WITHIN 15 SECONDS (HEARD OVER THE PHONE). THE RN ALSO SAID THAT THE INITIAL PURGE SOUNDED DIFFERENT FROM THE USUAL FIRST PURGE BEAT, STATING IT ONLY LASTED ABOUT HALF AS LONG AND SOUNDED LIKE IT WAS "GETTING CUT SHORT" AND NOT "ALLOWED TO COMPLETE THE PURGE." THE CSS EXPLAINED THAT THE PUMP WAS PROBABLY EXPERIENCING A VALVE ISSUE AND THAT THE PUMP NEEDED TO BE CHECKED OUT BY BIOMED. THE CSS ALSO EXPLAINED THAT THERE IS NOTHING THEY CAN DO CURRENTLY TO CHANGE THE SITUATION. PER THE CSS THE RN WILL NEED TO FOLLOW THE TRANSPORT TEAM'S PROTOCOL AT THIS POINT ON RECEIVING ANOTHER PUMP/ TAKING THE HOSPITAL'S PUMP FOR THE TRANSPORT. THE RN VERBALIZED UNDERSTANDING. THE CSS RECEIVED NO FURTHER CALLS. AT 4:40 PM MT IT WAS REPORTED VIA A CALL THAT THE PATIENT WAS TRANSPORTED WITHOUT ANY PROBLEMS TO THE DESTINATION USING THE HOSPITAL PUMP FROM THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84115 AEROAUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON