BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUME SET FOR UV FLASH

    MDR report key: 1706158 · Received June 2, 2010

    Report

    Report Number
    1423500-2010-00983
    Event Type
    Malfunction
    Date Received
    June 2, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS VISUALLY INSPECTED AND PRESSURE TESTED. NO ABNORMALITY WAS OBSERVED. THIS REPORT OF A LEAK IN THE CASSETTE COULD NOT BE CONFIRMED OR DUPLICATED IN THE LAB. BAXTER WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A LEAK DURING PATIENT USE WITH THE YUME SET. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE SELECTOR 24 KHZ MICRO HANDPIECE WAS USED DURING A CRANIOTOMY FOR TUMOR REMOVAL. IT WAS REPORTED THAT THE PRODUCT DID NOT PROVIDE ANY MISTING. THIS HANDPIECE WAS USED ALONG WITH THE CUSA NXT CONSOLE AND SERVICE MODULE (MFR REPORT NUMBERS 1222895-2010-00016 AND 1222895-2010-00017). THERE WAS A DELAY IN SURGERY OF ONE HOUR. THERE WAS NO HARM TO THE PATIENT. THE TUMOR WAS REMOVED. CROSSED REFERENCED TO MANUFACTURER REPORT NUMBER 8010219-2010-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUME SET FOR UV FLASH SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1