BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 3232056 · Received July 17, 2013

    Report

    Report Number
    2015691-2013-20626
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE ACTUAL COMPLAINT UNIT. 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. IT COULD NOT BE DETERMINED 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

    AS REPORTED, THE ARTERIAL PRESSURE IS NOT ACCURATE. ARTERIAL PRESSURE IS CONTROLLED BY OTHER MEASUREMENT. ALL AIR WAS REMOVED FROM THE BAG AND LINES BEFORE USE. THE TRANSDUCER WAS LEVELED AT HEART (ATRIUM) LEVEL. THERE WAS NO TYPE OF ALERT AND NO PATIENT INJURY. OTHER DEVICES RELATED TO THE SYSTEM (CABLE AND MONITOR) HAVE NOT BEEN REVISED FOR POSSIBLE ERRORS. THE CABLE WAS COMPATIBLE WITH THE MONITOR THAT WAS USED (SOLAR 8000 GE GENERAL ELECTRONICS). MODEL AND LOT NUMBER OF THE CABLE IS UNKNOWN. ALL CABLE CONNECTIONS WERE CHECKED FOR PROPER CONNECTION AND THE SET UP; THE PROCEDURE WAS FOLLOWED ACCORDING TO THE DFU. THE CUSTOMER CHANGES THE VENTED CAP TO A NON-VENTED CAP, AS RECOMMENDED. WHEN THEY WAITED 15 MINUTES AND REOPENED THE VENT PORT THEY SAW THAT THE ZERO LINE WAS UP TO 30 SOMETIMES EVEN 40. SO THEY HAD TO DO THE ZEROING AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332633 DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T328201A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1