BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5FR - 40 CC

    MDR report key: 4120930 · Received July 28, 2014

    Report

    Report Number
    1219856-2014-00134
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL FROM THE CARDIOVASCULAR UNIT RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) ON (B)(6) 2014 AT 6:10 AM (B)(6) THAT THE RN WAS CALLING BECAUSE THE ARTERIAL PRESSURE WAVE FORM FROM THE IAB WAS DAMPENED. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE SHEATH VIA RIGHT FEMORAL ARTERY ON (B)(6) 2014 WITHOUT ISSUE. WHEN THE CSS SPOKE WITH THE RN, THE RN STATED THAT THE ARTERIAL PRESSURE WAVEFORM ON THE AUTOCAT2WAVE (S/N (B)(4)) WAS VERY POOR AND THE READINGS ON THE PUMP WERE 213/213/213/213. THE RN HAS TRIED TO FLUSH, RE-ZERO, AND REPOSITION THE PATIENT BUT THERE WAS NO CHANGE TO THE WAVEFORM OR PRESSURE READINGS. THE CSS HAD THE RN SHAKE THE TRANSDUCER TUBING TO MAKE SURE CHANGES COULD BE SEEN AND THERE WAS MOVEMENT. THE CSS HAD THE RN DISCONNECT THE TRANSDUCER SET-UP FROM THE IAB AND CONNECT IT TO THE BEDSIDE MONITOR. INITIALLY THERE WAS A LITTLE ARTERIAL PRESSURE WAVEFORM BUT THEN IT ALSO BEGAN TO DAMPEN OUT AND BECOME A MEAN ARTERIAL PRESSURE. THE CSS HAD THE RN ASPIRATE THE CENTRAL LUMEN AND THE RN WAS UNABLE TO GET ANY BLOOD BACK. THE CSS EXPLAINED THAT THE CENTRAL LUMEN WAS CLOTTING OFF AND THAT THEY WOULD NEED TO HAVE ANOTHER ARTERIAL PRESSURE LINE INSERTED OR EXCHANGE THE IAB. THEY WERE PLANNING TO WEAN THE PATIENT TODAY FROM THE INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT WAS STABLE. THE CSS ALSO TRIED TO SEE IF THERE WAS AN ADEQUATE PRESSURE WAVEFORM FROM THE SIDE-PORT OF THE SHEATH, BUT IT WAS VERY DAMPENED. THE CENTRAL LUMEN OF THE IAB HAD HEPARINIZED SALINE IN THE TRANSDUCER SET-UP AND THE PATIENT WAS ALSO ON A HEPARIN DRIP. THERE WERE NO PUMP STRIPS GENERATED OR X-RAYS PERFORMED FOR REVIEW. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THE PATIENT OUTCOME IS STABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014 STATED THE CSS BELIEVED THEY WERE GONG TO WEAN THE PATIENT THE DAY THE PLACED THE CALL TO THE HOT-LINE. THE PATIENT WAS STABLE. WHEN THE CSS EXPLAINED THAT THE CENTRAL LUMEN WAS CLOTTED OFF, THE CSS TOLD THEM THAT THEY WOULD EITHER NEED TO REPLACE THE IAB OR GET ANOTHER ARTERIAL LINE TO THE PUMP IN ORDER TO TIME THE IAB. THE CSS DIDN'T THINK THEY WERE PLANNING TO REPLACE THE IAB SINCE THEY WERE PLANNING TO WEAN THE MALE PATIENT OFF IABP THERAPY THAT DAY. THE CSS GUESS IS WHEN THE CALLED THE PHYSICIAN THEY WOULD HAVE JUST ELECTED TO GO AHEAD AND REMOVE THE IAB AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439773 IAB: 7.5FR - 40 CC INTRA-AROTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1