BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION 7 FR. 40CC IAB

    MDR report key: 3946399 · Received July 7, 2014

    Report

    Report Number
    2248146-2014-00166
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CONDITION RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. TWO KINKS WERE FOUND ON THE CATHETER TUBING. ONE LOCATED 35.3CM FROM THE IAB TIP AND ONE LOCATED NEAR THE CATHETER/Y-FITTING JUNCTION APPROX 75.9CM FROM THE IAB TIP. THE OPTICAL FIBER WAS FOUND TO BE BROKEN AT THIS LOCATION. CONCLUSION: A SEVERE KINK IN THE CATHETER COULD A BREAK IN THE OPTICAL FIBER RESULTING IN LOSS OF SENSOR FUNCTION AND CAUSING REPORTED ALARMS. THIS TYPE OF FAILURE CAN BE CAUSED BY KINKS IN THE CATHETER OR PT MOVEMENT DURING THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

    Description of Event or Problem · 1

    HOSPITAL WAS UNABLE TO READ THE FIBER OPTIC (NO SIGNAL FROM FIBER OPTIC). ALARM "UNABLE TO CALIBRATE IAB." NURSE FROM (B)(6) CALLED STATING WHILE IN THE OPERATING ROOM, THEY WERE RECEIVING THE UNABLE TO CALIBRATE MESSAGE. SHE PRESSED THE ZERO KEY WHILE PUMPING AND STILL RECEIVED THE MESSAGE. THE PT IS NOW IN THE (B)(6) AND THEY ARE STILL NOT ABLE TO CALIBRATE AFTER ABOUT TWO HOURS. THEY DO NOT HAVE PRESSURE NUMBERS DISPLAYED. THEY ARE TRIGGERING OFF ECG AND THE BALLOON WAVEFORM LOOKS NORMAL. THE RADIAL ARTERIAL LINE WAS READING 100/50. MAQUET CA ACCOUNT MANAGER ASKED HER TO PERFORM ANOTHER CALIBRATION WHICH WAS SUCCESSFUL. SHE CHECKED FOR KINKS IN THE TUBING AND SAID THERE WERE NO RESTRICTIONS. MAQUET CA ACCOUNT MANAGER (RN) ASKED HER IF THE FILL MODE IS IN AUTO AND SHE SAID YES. THE SLIGHT POSSIBILITY THAT THE TIP OF THE CATHETER MAY BE UP AGAINST THE WALL WAS DISCUSSED. IT IS NOT READING ANY PULSATILITY. SUGGESTED SHE DISCONNECT THE OPTICAL SENSOR AND USE A STANDARD PRESSURE TRANSDUCER AND USE AN ALTERNATIVE ARTERIAL SOURCE. ASKED HER TO SAVE THE CATHETER. UPDATE: (B)(4) 2011, RECEIVED EMAIL FROM MAQUET CA TERRITORY MANAGER INDICATING THAT THE RN FROM (B)(6) STATED THAT THE PT'S DEATH WAS NOT THE FAULT OF THE IAB OR IABP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394774 SENSATION 7 FR. 40CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0434 2587

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death