BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 9881651 · Received March 25, 2020

    Report

    Report Number
    2015691-2020-11143
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    January 25, 2020
    Report Date
    March 3, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXO
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EXPECTED TO BE RETURNED, HOWEVER, IT WAS THEN LATER CONFIRMED THAT THE DEVICE WAS NO LONGER AVAILABLE. THE PATIENT DEMOGRAPHICS WERE RECEIVED. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR CAN A ROOT CAUSE OR ANY POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. WITH ANY HEMODYNAMIC MONITORING, PATIENT PARAMETERS CAN CHANGE QUICKLY AND DRAMATICALLY. THESE DEVICES ARE USED BY HIGHLY TRAINED CLINICIANS EXPERIENCED IN ASSESSING AND MITIGATING ANY HAZARDS THAT ARISE. THESE DEVICES ARE TYPICALLY USED IN INTENSIVE CARE UNITS OR OPERATING ROOMS WHERE PATIENTS ARE CLOSELY MONITORED. IT IS UNKNOWN WHETHER ANY USER OR PROCEDURAL FACTORS CONTRIBUTED TO THIS REPORTED EVENT. 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 · 0

    THIS WAS REPORTED IN ERROR AS EDWARDS DOES NOT HAVE REPORTING RESPONSIBILITY. THIS IS A THIRD PARTY PRODUCT THEREFORE EDWARDS DOESN'T HAVE RISK ASSESSMENT RESPONSIBILITIES ON IT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS AS WELL AS THE DEVICE HISTORY RECORD. 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.

    Description of Event or Problem · 1

    AS REPORTED, DURING USE ON A TRAUMATIC HEAD INJURY PATIENT, THE INTRACRANIAL PRESSURE (ICP) ELEVATED TO 25, WHILE USING THIS TRUWAVE CABLE. THE ARTERIAL TRANSDUCER LINE VALUES WERE FAULTY. THE PATIENT¿S BLOOD PRESSURE BEGAN READING 230/130 WITH A DECENT TRACE AND NO INTERVENTION. WHEN MORE SEDATION WAS GIVEN, THE BLOOD PRESSURE CAME DOWN TO 170/130. NORADRENALINE WAS REDUCED FROM 14 TO 4. TRACE DID NOT INDICATE A FALSE READING. THE NON-INVASIVE BLOOD PRESSURE READ 80/50 AND THE HEART RATE WAS UP TO 120. THE TRANSDUCER CABLE WAS CHANGED TO A DIFFERENT ONE WHICH GAVE THE CORRECT BLOOD PRESSURE READING CONCURRENT WITH THE NON-INVASIVE BLOOD PRESSURE. THE PATIENT WAS STABILIZED BY INCREASING NORADRENALINE TO GIVE THERAPEUTIC BLOOD PRESSURE WHICH RESOLVED THE ELEVATED ICP. THE DOCTOR WAS PRESENT DURING THE WHOLE PROCESS. THE PATIENT STABILIZED QUICKLY WITHIN 3 MINUTES AFTER CHANGING THE CABLE. LATER, THE CLINICAL ENGINEER CHECKED THE CABLE WITH A TRANSDUCER AND THERE WAS NO PRESSURE SHOWN ON THE MONITOR DESPITE PRESSURE BEING APPLIED TO THE TRANSDUCER. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THERE WERE NO ERROR MESSAGES DISPLAYED, ONLY THE ALARM FOR HYPERTENSION THAT WAS SET IN THE ALARM LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345243 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES 896507001 155009867

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR