BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESEP CENTRAL VENOUS OXIMETRY SET

    MDR report key: 2772191 · Received October 4, 2012

    Report

    Report Number
    2015691-2012-18393
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE TRIPLE LUMEN PRESEP CATHETER WITH VARIOUS COMPONENTS WAS RETURNED FOR EVALUATION. THE GUIDEWIRE WAS RECEIVED DAMAGED. THE RETURNED GUIDEWIRE HAD A BROKEN WELD ON THE 'J' TIP END AND THE OUTER COIL WIRE WAS UNRAVELED OVER A 17CM AREA. THIS CONDITION MAY OCCUR IF THE 18 GAUGE NEEDLE IS NOT IN THE CORRECT ORIENTATION (ARROW UP) INDICATING THAT THE NEEDLE BEVEL IS ALSO UP MAKING IT LESS LIKELY TO CATCH ON THE GUIDEWIRE. DUE TO THE WIRE BEING REMOVED FROM THE NEEDLE IT WAS UNABLE TO DETERMINE THE CAUSE OF THE WIRE BECOMING STUCK. A NEW GUIDEWIRE WAS PASSED THROUGH THE RETURNED NEEDLE WITHOUT ANY RESTRICTIONS OBSERVED. PER THE IFU "THE GUIDEWIRE SHOULD NEVER BE FORCED, IF DIFFICULTY IS MET DURING INSERTION OF THE GUIDEWIRE, COMPLETELY REMOVE THE GUIDEWIRE AND REATTEMPT INSERTION." VISUAL EXAMINATIONS WERE PERFORMED AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. ALTHOUGH THE COMPLAINT WAS CONFIRMED, THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE FOUND DURING THE EVALUATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE GOT STUCK INSIDE THE THIN-WALL NEEDLE DURING AN ATTEMPT TO PLACE THE DEVICES. THE NEEDLE AND WIRE WERE REMOVED TOGETHER FROM THE PATIENT AND NO INJURY OCCURRED. AFTER THE COMPONENTS WERE REMOVED FROM THE PATIENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE FROM THE NEEDLE "FORCIBLY" AND THE GUIDEWIRE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP CENTRAL VENOUS OXIMETRY SET PRESEP CATHETER DQE EDWARDS LIFESCIENCES, PR X3820HSJD

    Patients

    Seq Age Sex Outcome Treatment
    1