BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT

    MDR report key: 8445758 · Received March 22, 2019

    Report

    Report Number
    2015691-2019-00998
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 1, 2019
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION ASSESSMENT CONCLUDED THAT THE REPORTED EVENT CORRESPONDS TO A THIRD PARTY SUPPLIER (AMPHENOL ADVANCED SENSORS PR LLC.) A SUPPLIER NOTIFICATION WAS SENT TO INFORM THEM OF THIS EVENT.

    Additional Manufacturer Narrative · 0

    ONE DOUBLE DPT KIT WITHOUT THE IV LINE WAS RETURNED FOR EXAMINATION. THE REPORTED EVENT OF PRESSURE READING ISSUE WAS CONFIRMED. INITIALLY, THE RED DPT ZEROED AND SENSED PRESSURE ACCURATELY ON A PRESSURE MONITOR. HOWEVER, THE PRESSURE DID SHOW DRIFTING DURING OUTPUT DRIFT TESTING AND DID NOT MEET SPECIFICATION. ELECTRICAL TESTING SHOWED THAT THE DPT ELECTRONIC COMPONENTS WERE INTACT BECAUSE BOTH INPUT AND OUTPUT IMPEDANCES WERE WITHIN SPECIFICATIONS. ZERO-OFFSET ALSO MET SPECIFICATION. NO OTHER VISIBLE DEFECT WAS FOUND FROM THE DPT CABLE CONNECTOR. SUBSEQUENTLY, THE BLUE DPT ZEROED AND SENSED PRESSURE ACCURATELY ON A PRESSURE MONITOR. THE PRESSURE DID NOT SHOW ANY DRIFT DURING OUTPUT DRIFT TESTING AND MET SPECIFICATION. CORROSION WAS OBSERVED AT THE CONTACT PLATES OF THE DPT CABLE CONNECTOR. THE CORROSION WAS LIKELY CAUSED BY LIQUID/SALINE. THE IFU INDICATES NOT TO EXPOSE ELECTRICAL CONNECTIONS TO FLUID CONTACT. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS. 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. PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENTS CLINICAL MANIFESTATIONS. IT IS INDICATED IN THE PRODUCT EVALUATION THAT THE CABLE CONNECTION WAS SUBJECTED TO FLUID INGRESS. THERE WERE NO PATIENT COMPLICATIONS NOTED. 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 PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER THE COMPLAINT CANNOT NOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION AND DEVICE HISTORY RESULTS WHEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE INACCURATE MEAN ARTERIAL PRESSURE (MAP) VALUES DURING USE OF A PRESSURE MONITORING SET ON A (B)(6) FEMALE PATIENT UNDERGOING CARDIAC SURGERY. APPROXIMATELY ONE HOUR INTO THE PROCEDURE, BUT PRIOR TO THE PATIENT BEING PUT ON BYPASS, THE CENTRAL VENOUS PRESSURE (CVP) LINE DISPLAYED A MAP OF APPROXIMATELY 40MMHG, SO THE TRANSDUCER WAS RE-ZEROED AND NORMAL VALUES WERE THEN DISPLAYED. NO ERROR MESSAGE WAS NOTED AND THERE WAS NO ALARM, BUT THE CUSTOMER NOTED THAT THEY EITHER SILENCE ANY ALARMS OR GO INTO BYPASS MODE, WHICH DOES NOT ALARM. IN ANY EVENT, AN ACCEPTABLE PRESSURE WAS DISPLAYED SO IT WOULD NOT HAVE ALARMED ACCORDING TO ANY LIMITS THAT THEY HAD SET. THE ISSUE WAS AGAIN NOTED WHILE THE PATIENT WAS ON BYPASS, WHEN VERY LITTLE PULSATION COULD BE PHYSICALLY OBTAINED. PER THE CUSTOMER¿S EXPLANATION, ONCE A PATIENT IS ON BYPASS AND FLOW IS OPTIMIZED, THEY UTILIZE VASOCONSTRICTORS TO RAISE THE MAP TO THEIR TARGET VALUE OF 70MMHG. IN THIS INSTANCE, THE DISPLAYED MAP VALUE WAS AROUND 80MMHG, SO THE CLINICIAN PREPARED TO RE-ZERO THE LINE BY OPENING THE TRANSDUCER TO AIR; HOWEVER, THE VALUE CHANGED TO 50MMHG INSTEAD OF THE EXPECTED 0MMHG. WHEN THE LINE WAS RE-ZEROED, THE VALUE REGISTERED AT 30MMHG. THIS RAISED CONCERN THAT THE PATIENT POTENTIALLY EXPERIENCED A PERIOD OF UNACCEPTABLE HYPOTENSION WITH A MAP OF APPROXIMATELY 30MMHG FOR 30-40 MINUTES, WHICH WAS UNKNOWN DUE TO THE HIGHER READING THAT WAS SHOWN ON THE MONITOR. THE PATIENT WAS NOT BEING MONITORED ON ANY OTHER DEVICE FOR CLINICAL COMPARISON AGAINST THE INCORRECT VALUES, THOUGH THE PERFUSIONIST HAD NOTED THE UNEXPECTED VALUES AND RE-ZEROED, AS DESCRIBED ABOVE. IT WAS NOTED THAT THE PATIENT WAS ¿ACTIVELY TREATED¿ FOR THE RISE IN BLOOD PRESSURE (BP) JUST BEFORE BYPASS, THOUGH THE SPECIFIC TREATMENT WAS UNSPECIFIED. IT WAS ALSO NOTED THAT THEY DID NOT USE ANY VASOCONSTRICTORS TO RAISE THE PATIENT¿S BP TO AN ACCEPTABLE LEVEL ON BYPASS BECAUSE THEY WERE LED TO BELIEVE THAT THE BP WAS OK. BECAUSE THE PATIENT WAS VASODILATED MUCH MORE THAN THEY THOUGHT, INSTEAD OF TREATING WITH CONSTRICTOR, THEY GAVE AN UNSPECIFIED BOLUS(S) OF EXTRA FLUID TO MAKE UP FOR THE INADEQUATE RETURN TO THE PUMP, WHICH KEPT REDUCING THE PUMP FLOW. IT WAS DUE TO THE UNUSUAL NEED FOR FLUID THAT LED THE CUSTOMER TO INVESTIGATE THE PROBLEM. IT WAS DEDUCED THAT THE ARTERIAL TRANSDUCER MUST HAVE BEEN ZEROED AT THE START OF THE PROCEDURE IN ORDER TO OBTAIN A DISPLAYED NUMBER; HOWEVER, WHEN THE LINE WAS CONNECTED TO ANOTHER TRANSDUCER WITHIN THE SET AT THE START OF THE SURGERY, THE READING HAD APPEARED HIGH, SO THEY HAD OPENED IT TO AIR AND FOUND A READING OF ABOUT 20MMHG, SO THE LINE WAS RE-ZEROED. THE CVP HAD THEN READ CORRECTLY THROUGHOUT THE CASE. THE TRANSDUCERS WERE CONNECTED TO A GE PATIENT DATA MODULE, WHICH IS BEING INVESTIGATED SEPARATELY. THE PATIENT DATA MODULE WAS BEING MONITORED BY A GE B850 MONITOR. THE TRANSDUCERS AND CABLE HAD BEEN EXTERNALLY WIPED DOWN WITH TRISTEL TO ENABLE HANDLING OF THE EQUIPMENT. THE EDWARDS 3-LINE TRANSDUCER ELECTRICAL CABLE WAS TESTED IN CLINICAL ENGINEERING AND NO FAILURE OR DAMAGE WAS FOUND. BOTH THE EDWARDS CABLE AND THE GE PATIENT DATA MODULE WORKED CORRECTLY. THERE WAS NO KNOWN PATIENT HARM. THE TRUWAVE, SENSOR, AND LINE WERE REMOVED WHILE IN OR RECOVERY AND THE PATIENT WAS MOVED TO A REGULAR WARD WITHIN THE USUAL TIMEFRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235662 PRESSURE MONITORING KIT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR T001657A 61705866

    Patients

    Seq Age Sex Outcome Treatment
    1