BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 6004660 · Received October 6, 2016

    Report

    Report Number
    1124841-2016-00349
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    September 14, 2016
    Report Date
    November 18, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD CODE #1: ACTUAL DEVICE EVALUATED. METHOD CODE #2: VISUAL INSPECTION. METHOD CODE #3: MANUFACTURING REVIEW. RESULTS CODE: NON-FUNCTIONAL DEFECT. CONCLUSIONS CODE: USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THE SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO MANUFACTURING ANOMALIES. EVALUATION OF THE RETURNED SAMPLE CONFIRMED THAT THE LUER WAS NOT ABLE TO LOCK AROUND THE THREADS ON THE RESERVOIR PORT. WHEN THE DESIGN OF THE 3CX RESERVOIR LID WAS COMPARED AGAINST THE DESIGN OF THE (B)(4) PRODUCT, OR 1CX RESERVOIR, IT WAS FOUND THAT THE WALL THICKNESS OF THE PORTS DIFFERED. THE WALL THICKNESS OF THE WALL OPPOSITE OF THE THREADS ON THE PORTS IS THICKER ON THE (B)(4) RESERVOIR PORTS. THIS THICKER WALL HELPS KEEP THE THREADS OF THE PORT AND LUER ENGAGED. THE LUERED PORTS ON THE RESERVOIR LID ARE CHECKED IN PROCESS FOR ISO 594-1, THE INTERNAL SEALING TAPER, USING A CALIBRATED LUER GAUGE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE LUER LOCK CONNECTIONS ON THE TOP OF THE RESERVOIR WOULD NOT LOCK APPROPRIATELY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657869 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC UE11

    Patients

    Seq Age Sex Outcome Treatment
    1