BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUME VIEW SENSOR

    MDR report key: 18572531 · Received January 24, 2024

    Report

    Report Number
    2015691-2024-00549
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Report Date
    March 22, 2024
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K152980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE THERMISTOR MANIFOLD WAS RECEIVED FOR EVALUATION. THE REPORT OF THERMISTOR MANIFOLD BROKE WAS CONFIRMED. THE LUER CONNECTION FOR CENTRAL VENOUS CATHETER OF VOLUMEVIEW MANIFOLD HAD BEEN COMPLETELY BROKEN OFF. BROKEN MALE LUER WAS NOT RETURNED. CROSS SURFACE OF BROKEN LUER WAS ROUGH AND UNEVEN. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM RETURNED UNIT. BASED ON FURTHER ENGINEERING INVESTIGATION, THE ROOT WAS DETERMINED TO BE INADEQUATE PRODUCT DESIGN SINCE THE CURRENT DESIGN OF THE MANIFOLD IS NOT STRONG ENOUGH TO WITHSTAND BENDING FORCE APPLIED IN THE FIELD DURING PRODUCT USE, NOR DOES THE DESIGN PROVIDE A GOOD GRIPPING LOCATION TO DISSIPATE THE EXCESSIVE FORCE. CORRECTIVE ACTIONS ARE BEING IMPLEMENTED IN ORDER TO ELIMINATE THE CAUSE OF THE NON-CONFORMITY AND PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT. PRA WAS GENERATED EARLIER.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. AN ENGINEERING INVESTIGATION WILL BE COMPLETED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. 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 · 0

    AS REPORTED, DURING THE AFTERMATH OF THROMBECTOMY ON BASILIARY TRUNK STROKE IN A 62-YEAR-OLD PATIENT, THE THERMISTOR MANIFOLD BROKE IN SEVERAL PIECES (2024-00103-01). AS PER CUSTOMER'S OPINION, THE CLINICAL CONSEQUENCES AND CURRENT CONDITION OF THE PATIENT IS OF RISK OF INFECTION AND BLOOD LOSS. THE NURSE NOTICED THE PROBLEM IMMEDIATELY AND REPLACED THE MEDICAL DEVICE, THEREFORE THERE WAS NO ACTUAL BLOOD LOSS. THERE WERE NO ADDITIONAL ACTIONS NEEDED TO BE PERFORMED. THIS IS HAPPENING FOR THE SECOND TIME (2024-00105-01) AND THERE WAS ALSO NO NOTION OF BLOOD LOSS IN THIS CASE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE FROM 2024-00103-01 WAS AVAILABLE FOR EVALUATION, HOWEVER, THE DEVICE FROM 2024-00105-01 WAS NOT AVAILABLE FOR EVALUATION. AS A SUMMARY, TWO MEDWATCH REPORT ARE BEING SUBMITTED, ONE FOR EACH EVENT (MEDWATCH #42201AND #42202).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247185 VOLUME VIEW SENSOR TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS EDWARDS LIFESCIENCES DR VLVCVT5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown