BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25RWC W/ RES

    MDR report key: 8864170 · Received August 6, 2019

    Report

    Report Number
    1124841-2019-00217
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    September 18, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450837
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (IDENTIFICATION OF EVALUATION CODES 4114, 3221, 4315). METHOD CODE: 4114 - DEVICE NOT RETURNED. RESULTS CODE: 3221 - NO FINDINGS AVAILABLE. CONCLUSIONS CODE: 4315 - CAUSE NOT ESTABLISHED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE WAS A PICTURE PROVIDED; HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED BY THAT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS AND RETENTION SAMPLE COULD NOT BE OBTAINED AND EVALUATED. A POSSIBLE ROOT CAUSE COULD BE THAT THE VENOUS LINE WAS ATTACHED TO THE QUICK DISCONNECT TOO TIGHTLY. AN AWARENESS TRAINING WAS SENT TO THE MANUFACTURING ASSOCIATES TO MAKE THEM AWARE OF THE EVENT AND TO ENSURE THE CONNECTION IS NOT OVER TIGHTENED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, 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).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE LUER LOCK ON TOP WAS TOO TIGHT. AS PER THE USER FACILITY, THEY NOTICED THAT BLUE CAP COMING OFF WHEN THEY WERE OPENING AND WHEN THEY WENT TO SWITCH MANIFOLD. THEY NOTICED HOW TIGHT THE LUER IS AND HAVE TO USE PLIERS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658716 STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25RWC UNKNOWN 00699753450837

    Patients

    Seq Age Sex Outcome Treatment
    1