BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING SET

    MDR report key: 11388883 · Received February 26, 2021

    Report

    Report Number
    2015691-2021-01585
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 3, 2021
    Report Date
    May 11, 2021
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SINGLE DPT KIT WITH AN IV SET AND PRESSURE TUBING WERE RETURNED FOR EXAMINATION. THE REPORTED EVENT OF UNKNOWN MATERIAL WAS FOUND INSIDE OF THE CONNECTION BETWEEN THE DPT AND IV TUBING WAS CONFIRMED. ALTHOUGH THE CUSTOMER REPORTED THAT THIS EVENT OCCURRED BEFORE USE AND UPON OPENING THE PACKAGE, PRIMING SOLUTION WAS FOUND IN THE TUBING AND THE DPT. TWO UNKNOWN BROWN MATERIALS WERE OBSERVED, ONE WAS INSIDE THE DPT FLUID PATH ON THE FEMALE LUER SIDE, AND THE OTHER ONE WAS AT THE CONNECTION BETWEEN THE DPT FEMALE LUER AND THE IV TUBING MALE CONNECTOR. THE MATERIALS WERE APPROXIMATELY 7 X 0.5 MM (INSIDE OF DPT FLUID PATH) AND 4 X 0.5MM (AT THE CONNECTION) IN SIZE. LEAKAGE WAS OBSERVED FROM THE CONNECTION BETWEEN THE DPT FEMALE LUER AND IV TUBING MALE CONNECTOR DURING LEAK TEST. THE MATERIALS STAYED AT THE SAME LOCATION AFTER 5 MINUTES OF CONTINUOUS FLUSHING. THE CONNECTION BETWEEN THE DPT FEMALE LUER AND IV TUBING MALE CONNECTOR WAS DISCONNECTED, AND THE BROWN MATERIALS WERE REMOVED FOR FURTHER EVALUATION AND ANALYSIS. NO LEAKAGE WAS OBSERVED THROUGHOUT THE KIT AFTER REMOVING THE BROWN MATERIALS. IT APPEARED THAT THE BROWN MATERIAL AT THE CONNECTION HAD INTERFERED WITH THE TIGHT CONNECTION BETWEEN THE LUERS AND CREATED LEAKAGE PATH. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE CHEMISTRY RESULTS ARE RECEIVED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. IT IS COMMON CLINICAL PRACTICE TO INSPECT ALL PRODUCTS BEFORE USAGE. ADDITIONALLY, THESE PRODUCTS ARE USED BY HIGHLY TRAINED CLINICIANS, EXPERIENCED IN IDENTIFYING AND MITIGATING ANY HAZARDS THAT ARISE. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE NOTED PARTICULATE WAS NOT ABLE TO BE FLUSHED OUT DURING 5 MINUTES OF CONTINUOUS FLUSHING. 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

    THE REPORTED EVENT OF CONTAMINATION WAS CONFIRMED. THE FOUND UNKNOWN BROWN MATERIAL WAS CONSISTENT WITH THAT OF CELLULOSE. SINCE THE DEVICE WAS SUPPLIER RELATED ISSUE, THE SUPPLIER WAS NOTIFIED ABOUT THE COMPLAINT. IT IS COMMON CLINICAL PRACTICE TO INSPECT ALL PRODUCTS BEFORE USAGE. ADDITIONALLY, THESE PRODUCTS ARE USED BY HIGHLY TRAINED CLINICIANS, EXPERIENCED IN IDENTIFYING AND MITIGATING ANY HAZARDS THAT ARISE. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE NOTED PARTICULATE WAS NOT ABLE TO BE FLUSHED OUT DURING 5 MINUTES OF CONTINUOUS FLUSHING. 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 · 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 AN UNKNOWN MATERIAL WAS FOUND INSIDE THE DISPOSABLE PRESSURE TRANSDUCER. IT WAS IN THE CONNECTION BETWEEN THE DPT AND IV TUBING, IN AN OPENED PACKAGE, BEFORE USE. PATIENT DEMOGRAPHIC INFORMATION REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280406 PRESSURE MONITORING SET PRESSURE MONITORING KIT DXO EDWARDS LIFESCIENCES DR PXMK10204 NP0566MT

    Patients

    Seq Age Sex Outcome Treatment
    1