BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 3041636 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19770
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY THE PRODUCT IN QUESTION WAS DISPOSED OF BY THE HOSPITAL. IT WAS FURTHER STATED THAT THE PRESSURE DIFFERENCE BETWEEN THE TRANSDUCER AND BALLOON PUMP WAS AROUND 50MMHG. THERE WAS NO PATIENT INJURY. THE DPT INSTRUCTIONS FOR USE PROVIDE THE FOLLOWING INFORMATION AND GUIDANCE RELATED TO ABNORMAL PRESSURE READINGS: PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM. WARNING: ABNORMAL PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT'S CLINICAL MANIFESTATIONS. VERIFY TRANSDUCER FUNCTION WITH A KNOWN AMOUNT OF PRESSURE BEFORE INSTITUTING THERAPY. CAUTION: SIGNIFICANT DISTORTION OF THE PRESSURE WAVEFORM OR AIR EMBOLI CAN RESULT FROM AIR BUBBLES IN THE SETUP. NOTE: POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. WITHOUT RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF DAMAGES OR DEFECTS WERE PRESENT ON THE DPT. IT REMAINS UNKNOWN IF ANY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOOD PRESSURE IS NOT CORRELATING WITH THE BALLOON PUMP. IT WAS FURTHER STATED THAT THE TUBING WAS ALSO FOUND TO BE HARDER THAN IT USED TO BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144015 CUSTOM DEFINED PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T270004B 59270414

    Patients

    Seq Age Sex Outcome Treatment
    1