BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA THERAPEUTIC PLASE EXCHANGE SET

    MDR report key: 1952141 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00122
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    August 24, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INLET LUER CONNECTORS WAS RETURNED FOR INVESTIGATION. THE LUER WAS VISUALLY INSPECTED AND MALE PORTION OF THE CONNECTOR WAS COMPLETELY MISSING FROM THE LUER CONNECTOR. THERE IS SOME CRAZING NOTED WHERE THE MALE PORTION OF THE CONNECTOR WAS MOLDED TO THE LUER BUT THIS COULD BE FROM THE CONNECTOR BREAKING AT THE BASE. CARIDIANBCT MOLDING ENGINEERS REVIEWED THE COMPONENT AND THE FAILURE AND BELIEVE THAT EITHER THERE WAS AN ERROR WHERE SOME MATERIAL WAS STILL IN THE MOLD WHEN THE NEXT SHOT WAS INJECTED, CAUSING A DIFFERENCE IN MATERIAL CONDITION (TEMPERATURE, PRESSURE, ETC), THEREFORE CREATED A BAD PART, OR WHEN THE MACHINE WAS BACKING THE LUER OUT OF THE MOLD, IT WEAKENED THE MALE PORTION SUFFICIENTLY TO BREAK WHEN IT USE. CARIDIANBCT MOLDING ENGINEERS ARE ALSO CONFIDENT THAT DUE TO THE PROPERTIES OF THIS MATERIAL IT IS HIGHLY UNLIKELY THAT IT WOULD CRUMBLE INTO SMALL PIECES. IT IS MORE LIKELY THAT IT WILL BREAK IN ONE PIECE. CARIDIANBCT MOLDING ENGINEERS VISITED THE VENDER OF THIS PART. THE VENDOR'S OPERATORS HAD NOT SEEN THAT TYPE OF FAILURE. THEY REVIEWED THEIR PRODUCTION RECORDS AND NOTHING SIMILAR WAS NOTED. CARIDIANBCT COMPLAINT INVESTIGATORS TOOK 20 LUERS FROM OUR PRODUCTION STOCK AND CONDUCTED CHEMICAL STRESS TESTING; TO ENSURE NO COMPOSITION CHANGES HAD OCCURRED AND THE ENSURE THE PARTS WERE ANNEALED. THE COMPONENTS WERE LOOKED AT FOR CRACKS AND CRAZING AND NONE WERE FOUND. ALL COMPONENTS WERE THEN OVER-TIGHTEN AND LOOSENED WITH A FEMALE LUER AND NO CRACKS OR BREAKS WERE OBSERVED. CONCLUSION: A DEFECTIVE LUER CAUSED THIS EVENT. THE CAUSE OF THE DEFECT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE CUSTOMER REPORTED THAT THE MALE TIP OF THE LUER CONNECTION ON THE RETURN LINE BROKE AND REMAINED INSIDE THE PATIENT'S CATHETER. THE RADIOLOGIST CLOSED THE LINE, THEREFORE, REMOVING THE RISK OF AIR CONTAMINATION. LATER THE RADIOLOGIST WAS ABLE TO REMOVE THE MALE PORTION OF THE LUER FROM THE PATIENT'S CATHETER AND A NEW CENTRAL LINE WAS NOT REQUIRED. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR INJURY FROM AIR ENTERING THE CENTRAL LINE OR THE NEED FOR REPLACEMENT FOR THE CENTRAL LINE DUE TO THE OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA THERAPEUTIC PLASE EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT NA 07S15260

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R