BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 9 FR - 50 CC

    MDR report key: 3983380 · Received July 7, 2014

    Report

    Report Number
    1219856-2014-00126
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K010330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL TO THE HOTLINE FROM THE CARDIAC CARE UNIT RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) ON (B)(6) 2014 AT 1509 EST THAT THE RN CALLED DUE TO FREQUENT HE (HELIUM) LOSS ALARMS ON THE AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP. THE INTRA-AORTIC BALLOON (IAB-R950-U) WAS JUST INSERTED THROUGH THE SHEATH VIA FEMORAL WHILE IN THE CARDIAC CARE UNIT. THE PATIENT WS HAVING A LOT OF ECTOPY AND THE RN THOUGHT THAT MAY BE THE REASON. THERE WAS NO BLOOD NOTED IN THE TUBING. THE PUMP WAS ACHIEVING THE GOALS OF THERAPY FOR THE PATIENT. THE PUMP WAS CURRENTLY IN OPERATOR MODE 1:1, PATTERN TRIGGER, 50CC IAB. THE PATIENT HAD A FAIR AMOUNT OF ADIPOSE TISSUE AT THE INSERTION SITE NO VISIBLE KINKS. THE CSS HAD THE RN SWITCH BACK TO AUTOPILOT MODE, THE TRIGGER CHANGED TO PEAK AND WE DECREASED THE VOLUME IN SEVERAL INTERVALS TO 45CC AND ATTEMPTED 1:2 WITH THE ALARM STILL FREQUENTLY OCCURRING. THE CSS REQUESTED A STRIP, BUT THE RN HAD NO WAY TO SEND ONE SO THE RN TOOK A SCREENSHOT AND EMAILED IT TO THE CSS. BASED ON THE BPW (BALLOON PRESSURE WAVEFORM) NO SIGNIFICANT KINK WAS NOTED. THE CSS WALKED THE RN THROUGH A LEAK TEST. NO DECREASE IN BASELINE OR LEAK NOTED. THE CSS EXPLAINED TO THE RN THIS MEANT THAT THE ISSUE WAS WITHIN THE IAB AND REMOVAL WAS RECOMMENDED. THE RN STATED CALLING THE DOCTOR. THE RN WILL KEEP THE IAB AFTER REMOVAL. THE CSS REMINDED THE RN THAT THE IAB MUST BE REMOVED AS SOON AS POSSIBLE AND WITHIN 30 MINUTES TO AVOID CATHETER ENTRAPMENT; THE RN UNDERSTOOD. AT 1631 EST, THE CSS SPOKE WITH THE SAME RN. THE IAB WAS REMOVED WITHOUT DIFFICULTY, NO PATIENT COMPLICATIONS WERE NOTED. THEY PLACED A 40CC IAB WHICH WAS NOW PUMPING WITH NO ALARMS AND ACHIEVING THE GOALS OF THERAPY. THE CSS ALSO SPOKE TO THE SALES REPRESENTATIVE WHO IS ON SITE AND WILL PICK UP THE IAB. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION WHILE IAB WAS REMOVED AND A NEW IAB PREPPED AND INSERTED SUCCESSFULLY. THE PATIENT OUTCOME IS THE PATIENT IS STABLE AND RECEIVING IABP THERAPY AS PLANNED. AN UPDATE RECEIVED ON (B)(6) 2014 FROM THE SALES REPRESENTATIVE REPORTED THAT THEY SWITCHED TO A 40 CC BECAUSE THERE WAS NOT ANOTHER 50 CC IMMEDIATELY AVAILABLE. THE 40 CC THAT WAS USED WAS AN ARROW IAB-06840-U WHICH WAS INSERTED VIA THE SAME INSERTION SITE. THE DELAY OR INTERRUPTION IN THERAPY WAS "JUST A FEW MINUTES" ACCORDING TO THE RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395060 IAB: 9 FR - 50 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1