BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7FR 40CC IAB

    MDR report key: 4008584 · Received July 22, 2014

    Report

    Report Number
    2248146-2014-00140
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER AND BETWEEN AND CATHETER AND THE SHEATH. THREE KINKS WERE FOUND ON THE OUTER CATHETER TUBING APPROXIMATELY 554.1 CM 54.9 CM AND 75.9 CM FROM THE IAB TIP. IT IS DIFFICULT TO DETERMINE WHEN THE KINKS OCCURRED. THEY MAY HAVE OCCURRED DURING IAB REMOVAL, DURING IABP THERAPY, FROM PATIENT MOVEMENT, OR WHILE PACKING/SHIPPING THE IAB BACK FOR EVALUATION. PRODUCT EVALUATION: A SENSOR OUTPUT TEST WAS PERFORMED AND THE SENSOR WAS FOUND TO BE WITHIN SPECIFICATION. AN UNDERWENT LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, AND EXTRACORPOREAL TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. CONCLUSION: THE REPORTED EVENTS CANNOT BE CONFIRMED BY THE EVALUATION. IF A PROBLEM OCCURS MONITORING THE ARTERIAL PRESSURE, THE INSTRUCTIONS FOR USE INDICATES TO PROVIDE AN ALTERNATE PRESSURE SOURCE BY CONNECTING A CONVENTIONAL ARTERIAL PRESSURE SIGNAL (RADIAL ARTERY) OR PRESSURE SIGNAL TO THE PUMP. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

    Description of Event or Problem · 1

    ICU NURSE CALLED WITH AN UNABLE TO CALIBRATE IAB OPTICAL SENSOR MSG. THE PROBLEM BEGAN WITH BLOOD DETECTED ALARM. FINDING NO BLOOD IN THE CATHETER THEY RESET THE ALARM BY TURNING THE PUMP OFF AND WHEN TI TURNED BACK ON THEY NEVER AGAIN GOT NUMBERS OR SUCCESSFUL CALIBRATION. THE PROBLEM HAD BEGUN APPROX 90 MIN. PRIOR TO THE ESP CALL WITH MULTIPLE CALIBRATION ATTEMPTS SINCE. THE PUMP WAS TRIGGERING ON ECG AND A NORMAL 1:1 ARTERIAL WAVEFORM WAS PRESENT ON THE PUMP SCREEN . THE BP WAS STABLE. THE PUMP WAS IN AUTO AND ATTEMPTS TO INITIATE A CALIBRATION BY PUSHING THE ZERO PRESSURE KEY RESULTED IN SUCCESSFUL AUTOFILL BUT AT THE END OF THE PROCESS THE UNABLE TO CALIBRATE MSG RESUMED IMMEDIATELY. RESEATING THE OPTICAL SENSOR RESULTED IN THE PUMP INITIATING A CALIBRATION BUT WAS AGAIN UNSUCCESSFUL. CHANGING TO ANOTHER CS300 PUMP SOLVED THE PROBLEM. I WALKED HER THROUGH THE PROCESS OF CHANGING PUMPS AND RESETTING THE AUGMENTATION ALARM. DATASHEET REPORTED: EXCHANGED BALLOON PUMP FOR ANOTHER BALLOON PUMP AND PROBLEM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428894 SENSATION 7FR 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0434 2752

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death