BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 2822589 · Received November 7, 2012

    Report

    Report Number
    2015691-2012-18616
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 18, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. 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 ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE ARTERIAL BLOOD PRESSURE MEASURED ON THE DPT, GRADUALLY INCREASED TO 230/180. THE CLINICIAN DOUBTED THE ACCURACY OF THE PRESSURE MEASUREMENT, SO THEY CHECKED IT MANUALLY (CUFF PRESSURE) AND GOT A READING OF 105/56. AFTER CHANGING THE TRANSDUCER, THE ARTERIAL PRESSURE MEASURED 105/51. AS REPORTED, THE NORADRENALIN WAS RESTARTED. NO ACTUAL INJURY WAS REPORTED; HOWEVER, THE CLINICIAN CONSIDERED THAT THEY HAD GIVEN A "LIFE-THREATENING PROGNOSIS AND AMINE TREATMENT" TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFINED PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T100209A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1