BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT

    MDR report key: 12141382 · Received July 9, 2021

    Report

    Report Number
    2015691-2021-03967
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 15, 2021
    Report Date
    August 20, 2021
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K183413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE FACILITY. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. PER THE IFU: POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, AND EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. THE ASSEMBLY MAY BE TESTED FOR DYNAMIC RESPONSE BY OBSERVING THE PRESSURE WAVEFORM ON AN OSCILLOSCOPE OR MONITOR. BEDSIDE DETERMINATION OF THE DYNAMIC RESPONSE OF THE CATHETER, MONITOR, KIT AND TRANSDUCER SYSTEM IS DONE AFTER THE SYSTEM IS FLUSHED, ATTACHED TO THE PATIENT, ZEROED AND CALIBRATED. A SQUARE WAVE TEST MAY BE PERFORMED BY PULLING THE SNAP TAB DEVICE AND RELEASING QUICKLY. PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM. ABNORMAL PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENTS CLINICAL MANIFESTATIONS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. H3 OTHER TEXT : DEVICE DISCARDED BY FACILITY

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE CONTROL STUDY THAT WAS REPORTED TO INVESTIGATE THE DIFFERENCE IN PRESSURE READINGS REPORTED UNDER THE INITIAL MDR WAS NOT PERFORMED AND IT WAS ONLY A SUGGESTION TO TRY TO FIND THE CAUSE OF SUCH DIFFERENCE IN VALUES THAT WERE REPORTED UNDER THE RELATED COMPLAINTS (2021-10676-01 MEDWATCH # 04861, 2021-10833-01 MEDWATCH # 04862, 2021-10836-01 MEDWATCH # 04863, 2021-10841-01 MEDWATCH # 04866, 2021-11726-01 MEDWATCH # 0954)

    Additional Manufacturer Narrative · 1

    FOLLOW UP IS ON GOING TO CLARIFY WHETHER THE DEVICES ARE AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION RESULTS. THE EXACT LOT NUMBER WAS UNKNOWN, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNABLE TO BE OBTAINED.

    Description of Event or Problem · 1

    AS REPORTED, DURING A CONTROL THAT WAS PERFORMED TO INVESTIGATE THE DIFFERENCE IN PRESSURE READINGS USING DISPOSABLE PRESSURE TRANSDUCERS (DPTS), THE HIGHER SYSTOLIC PRESSURE WAS 15 TO 30MMHG HIGHER THAN THE PRESSURE MEASURED BY THE CARDIOLOGIST. THE CONTROL WAS PERFORMED ON PATIENTS WHO UNDERWENT A CORONARY ANGIOGRAPHY OR PERCUTANEOUS CORONARY INTERVENTION AND THE SHEAT THAT WAS CONNECTED FOR EXAMINATION DURING THE INTERVENTION WAS USED FOR THIS CONTROL IN ORDER TO MAKE SURE THAT THE READINGS WERE TAKEN FROM THE SAME HEIGHT AND SIDE ON THE PATIENT. THE PRESSURE SET WAS RESET JUST BEFORE CONNECTING THE TRANSDUCER AND THE TRANSDUCERS WERE MAINTAINED AT THE SAME HEIGHT. DPTS WITH 1 THREE WAY STOPCOCK WERE USED, HOWEVER IN 3 CASES, THE MEASURE WAS INITIALLY DONE WITH A DPT WITH 2 THREE WAY TAPS AND THEN IT WAS DONE AGAIN WITH A DPT WITH THREE WAY TAPS. IN ONE OF THESE 3 CASES, THE SYSTOLIC BLOOD PRESSURE DROPPED BY 10MMHG BUT THERE WAS NO DIFFERENCE IN THE REST OF CASES. THE CARDIOLOGISTS USED PHILIPS HEMO SYSTEM WITH AN ACIST CVI, ANGIO TOUCH KIT AS THE PRESSURE TRANSDUCER. A MEASURE WAS PERFORMED USING AN ACIST CVI ANGIO TOUCH KIT TRANSDUCER AND A NAMIC CONVENIENCE KIT TRANSDUCER IN ORDER TO CHECK THE DIFFERENCE BETWEEN THE 2 TRANSDUCERS AND THE SAME VALUES WERE OBTAINED. THERE WAS NO ERROR MESSAGE DISPLAYED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE PRODUCT WAS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040721 PRESSURE MONITORING KIT PRESSURE MONITORING KIT DXO EDWARDS LIFESCIENCES DR DPTUNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 PHILIPS HEMO SYSTEM, ACIST KIT, NAMIC TRANSDUCER| PHILIPS HEMO SYSTEM, ACIST KIT, NAMIC TRANSDUCER