BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 20010948 · Received August 21, 2024

    Report

    Report Number
    2015691-2024-06225
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691957077
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. MODEL NUMBER ADDITIONAL 501(K) IS K171996. 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.

    Additional Manufacturer Narrative · 0

    ONE FLOTHRU DPT (DIFFERENTIAL PRESSURE TRANSMITTER) WITH BONDED STOPCOCKS WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE AND THAT THE TRANSDUCER SPUN FREELY WAS CONFIRMED. LEAKAGE WAS DETECTED FROM THE ONE WAY STOPCOCK BONDED CONNECTION WITH THE DPT. THE LOCK NUT OF THE ONE WAY STOPCOCK WAS STILL BONDED TO THE DPT HOUSING FEMALE LUER BUT THE MALE LUER HAD BEEN COMPLETELY BROKEN. AN ENGINEERING EVALUATION WAS COMPLETED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE POTENTIAL ROOT CAUSE FOR THE ISSUE WAS ATTRIBUTED TO MANPOWER. AS PART THE MANUFACTURING PROCESS, 100 PERCENT OF THE UNITS ARE VISUALLY INSPECTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PX600I HAD LEAKAGE. ISSUE WAS NOTICED AFTER CONNECTING THE DEVICE TO AN EXTERNAL VENTRICULAR DRAINAGE AND FLUSHING. LEAKAGE WAS LIKELY SALINE, BUT COULD HAVE BEEN A SMALL AMOUNT OF CEREBRAL SPINAL FLUID. UPON INVESTIGATION, THE RN DISCOVERED THAT THE DISTAL END OF THE TRANSDUCER SPUN FREELY. AT THIS POINT, SHE ATTEMPTED TO TIGHTEN THE CONNECTION BUT COULD NOT. ANOTHER SET WAS OPENED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152425 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PX600I 65763165 07460691957077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown