BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 3152679 · Received June 7, 2013

    Report

    Report Number
    2015691-2013-20274
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE SINGLE FLOTHRU DPT KIT WITH IV SET FOR EXAMINATION. THERE WAS NO VISIBLE BLOOD FOUND FROM THE KIT. THE DPT ZEROED AND SENSED PRESSURE ON A PRESSURE MONITOR. HOWEVER THE PRESSURE READINGS WERE NOT STABLE. A VISUAL EXAMINATION FOUND EXCESS SOLDER MATERIAL ON THE #1 AND #2 TRACES ON THE SENSOR CHIP. THE DPT ZEROED AND SENSED PRESSURE ACCURATELY AFTER REMOVAL OF THE EXCESS SOLDER MATERIAL. THE PRESSURE READINGS ALSO BECAME STABLE. IT APPEARED THAT THE EXCESS SOLDER ON TRACES AFFECTED FUNCTIONALITY OF THE DPT. THE DPT ELECTRONIC COMPONENTS WERE INTACT BECAUSE BOTH INPUT AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. THE ROOT CAUSE HAS BEEN DETERMINED TO BE MANUFACTURING RELATED. AS PART OF THE CORRECTIVE ACTION ALL OPERATORS WERE CERTIFIED IN SOLDERING TECHNIQUE, EFFECTIVENESS MONITORING IS UNDERWAY. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DPT DID NOT ZERO ON THE FIRST DAY OF USE. HOWEVER FOLLOW UP WITH THE CUSTOMER INDICATED THAT THERE WAS NO PROBLEM WITH THE MEASUREMENT IN THE BEGINNING, BUT THE BASELINE OF THE WAVEFORM GRADUALLY ROSE OVER TIME. THE VALUE SHOWED 220MMHG WHEN IT SHOULD BE AROUND 100MMHG. THE SENSOR WAS REPLACED AND THE PROBLEM WAS SOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252235 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PL1805TS_ ZT0671MT

    Patients

    Seq Age Sex Outcome Treatment
    1