BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX25 OXYGENATOR EAST

    MDR report key: 4791546 · Received May 20, 2015

    Report

    Report Number
    1124841-2015-00172
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    May 5, 2015
    Report Date
    July 30, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON MAY 20, 2015. (B)(4). THE ACTUAL DEVICE WAS VISUALLY INSPECTED UPON RECEIPT, AND THE REPORTED DAMAGE WAS CONFIRMED. DAMAGE WAS OBSERVED ON THE BLOOD INLET PORT CAP AND CORRESPONDING DAMAGE WAS OBSERVED ON THE BLOOD INLET PORT. ADDITIONAL MINOR DAMAGE WAS OBSERVED ON THE GAS OUTLET CAP, CONSISTENT WITH BOTH CAPS BEING DAMAGED AT THE SAME TIME AND CONSISTENT WITH SHOCK FORCE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. A RETENTION SAMPLE FROM THE SAME LOT WAS INSPECTED AND NO DAMAGE WAS OBSERVED. THE ROOT CAUSE OF THE DAMAGE HAS BEEN ATTRIBUTED TO SHOCK FORCE WHEN THE UNIT WAS OUTSIDE OF THE BOX. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS.UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED:(B)(4).ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT, OUT OF BOX, AN IRREGULAR HOLE WAS DISCOVERED IN THE CAP ON THE BLOOD-IN PORT. THE CAP WAS REMOVED AND THE INLET WAS FOUND TO BE DEFORMED. NO PATIENT INVOLVEMENT AS THIS OCCURRED OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328226 CAPIOX RX25 OXYGENATOR EAST BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*RX25RE TA19

    Patients

    Seq Age Sex Outcome Treatment
    1 NA