BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACAT 1 IAB PUMP ASSEMBLY

    MDR report key: 2980668 · Received February 22, 2013

    Report

    Report Number
    1219856-2013-00042
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K965209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RN IN THE INTENSIVE CARE UNIT (ICU) TO THE CLINICAL SUPPORT SPECIALIST (CSS) THAT SOON AFTER INSERTION AND ARRIVAL TO THE UNIT THE RN WANTED TO TROUBLESHOOT WHY THE PUMP IS "LOOSING VOLUME" IN THE INTRA-AORTIC BALLOON (IAB). THE RN STATED THEY HAVE CHANGED THE TANK AND CAN FIND NO APPARENT LEAK, BUT THE VOLUME DISPLAYED ON THE SCREEN CONTINUES TO DECREASE AND IS NOW AT 25CC. THE PUMP IS ACHIEVING THE GOALS OF THERAPY AND THERE HAS BEEN NO EFFECT ON THE PT'S PRESSURES. THE CSS REVIEWED WITH THE RN HOW THE INTRA-AORTIC BALLOON PUMP (IABP) WILL REDUCE VOLUME IN THE IAB IF TOO MUCH RESISTANCE IS MET AND THE IAB IS CONSIDERED TOO LARGE FOR THE AORTA. THE PT IS A (B)(6) FEMALE SLIGHTLY OVERWEIGHT WITH SOME ADIPOSE TISSUE AT THE INSERTION SITE. THE PT HR (HEART RATE) IS 86, NSR (NORMAL SINUS RHYTHM), PUMPING IN AUTOPILOT MODE 1:1. THE CSS EXPLAINED THAT A 30CC IAB (CURRENTLY IN USE) COULD BE REDUCED TO 20 CC WITHOUT CONCERN OF CLOT FORMATION ON THE CATHETER. THE RN STATED THAT NOW HE REMEMBERED THAT THE PUMP DOES THAT AUTOMATICALLY. THE RN ALSO MENTIONED GETTING A KINK AND HE (HELIUM) LOSS ALARM. THE CSS AND RN DISCUSSED KINKING AT THE INSERTION SITE DUE TO ADIPOSE TISSUE. WE REVIEWED THE BPW (BALLOON PRESSURE WAVEFORM) AND IT IS REPRESENTING SLOW HE DUE TO SLOPING AND SLOW RETURN OF THE GAS. THE CSS REMINDED THE RN THAT ALTHOUGH THIS IS LIKELY A KINKING ISSUE, THEY SHOULD CHECK FOR BLOOD IN THE CATHETER PERIODICALLY EVEN IF THE ALARM DOES NOT RETURN. THERE HAS BEEN NO BLOOD NOTED IN THE TUBING. AT THIS TIME THE RN GAVE THE PHONE TO THE NIGHT SHIFT NURSE COMING ON AND THE CSS REVIEWED ALL OF THE ABOVE WITH THE NIGHT SHIFT RN. THERE WAS ALSO A DISCUSSION ABOUT PT POSITIONING TECHNIQUES AND OBTAINING A CXR (CHEST X-RAY) TO VERIFY THE CATHETER IS STILL IN PROPER POSITION. THE CSS GAVE THE RN HER DIRECT NUMBER TO CALL IF SHE HAD ANY ADDITIONAL QUESTIONS. AT 0207 EST THE NIGHT SHIFT RN CALLED AND STATED THAT THEY HAD CHANGED OUT THE PUMP PER THE DOCTOR'S REQUEST BECAUSE OF THE ALARMS ALTHOUGH THEY DID NOT CONTINUE VERY OFTEN AFTER PT POSITIONING AND THE SECOND PUMP IS DECREASING THE VOLUME TO 15CC LIKE THE PREVIOUS PUMP. THE CSS TOLD THE RN THAT SHE COULD GIVE HER NUMBER TO THE DOCTOR FOR FURTHER EXPLANATION IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77584 ACAT 1 IAB PUMP ASSEMBLY INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON