BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 2946298 · Received February 6, 2013

    Report

    Report Number
    2015691-2013-19210
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES REP THAT INDICATED A NON-EDWARDS CATHETER (MFG. BY BECTON DICKINSON) WAS INVOLVED IN THE COMPLAINT. IT WAS FURTHER STATED, THE HOSPITAL DID ADDITIONAL TESTING AND TROUBLESHOOTING, WHICH INCLUDED RECALIBRATION OF ALL THE MONITORS AND EXCHANGING THE ARTERIAL CATHETER. THE CUSTOMER NOTED THAT SINCE THEY CHANGED FROM A SHORT TO A LONG ARTERIAL CATHETER, THEY DO NOT HAVE THE DIFFERENCE IN PRESSURES. AS THE EDWARDS DEVICE WAS FUNCTIONALLY TESTED AND FOUND TO BE WITHOUT DEFECT OR DAMAGE, AND THE CUSTOMER HAS EXCHANGED THE CATHETER WITH RESOLUTION OF THE DIFFICULTY, THIS EVENT IS NO LONGER CONSIDERED TO BE A REPORTABLE MALFUNCTION AND A CORRECTED REPORT IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 1

    ONE INCOMPLETE TRIPLE DPT - VAMP FLEX KIT WAS RETURNED FOR EVALUATION. THE IV SET AND PRESSURE TUBINGS WERE NOT RETURNED WITH THE KIT. PRIMING SOLUTION WERE VISIBLE INSIDE RETURNED KIT. BOTH DPTS ZEROED AND SENSED PRESSURE ACCURATELY ON A PRESSURE MONITOR. ELECTRICAL TESTING ALSO SHOWED THAT DPT ELECTRONIC COMPONENTS WERE INTACT; BOTH INPUT AND OUTPUT IMPEDANCES WERE WITHIN SPECIFICATION, PER THE APPLICABLE DRAWING. NO VISIBLE DEFECT WAS OBSERVED ON THE CABLE CONNECTORS. PRESSURE TESTS WERE PERFORMED AT VARIOUS PRESSURE VALUES, 0, 50, 100 AND 300 MMHG. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. THE COMPLAINT WAS NOT CONFIRMED DURING THE EVALUATION; THE DPTS FUNCTIONED NORMALLY. 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. NO DEFECTS OR DAMAGES WERE FOUND ON THE RETURNED UNIT; IT COULD NOT BE DETERMINED IF ANY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS ASSOCIATED WITH MDR REPORT # 2015691-2013-19209.

    Description of Event or Problem · 1

    AS REPORTED, THE PRESSURE TRACING ON THE ARTERIAL LINE SHOWED A NORMAL DIASTOLIC PRESSURE AND A VERY SPIKY AND VERY HIGH SYSTOLIC PRESSURE. WHEN COMPARED WITH THE NON-INVASIVE BLOOD PRESSURE, THE DIFFERENCE ON THE SETS VARIED BETWEEN 30MMHG AND 90MMHG. A DRAGER MONITOR WAS BEING USED WITH A "STANDARD" EDWARDS CABLE. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51349 CUSTOM DEFINED PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR DPTUNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1