BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 6048180 · Received October 21, 2016

    Report

    Report Number
    1124841-2016-00361
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 30, 2016
    Report Date
    December 2, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE (B)(4). (B)(4). CONCLUSION NOT YET AVAILABLE. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THAT FLUID WAS IN THE BACK HOUSING OF THE PUMP. A REVIEW OF THE DEVICE HISTORY REVEALED NO PRODUCTION RELATED ANOMALIES. THE SAMPLE WAS BUILT INTO A SALINE CIRCUIT AND THEN SET UP ON A SARNS DRIVE MOTOR. THE RPM WERE SET AT 900 AND RAMPED UP BY 300RPM EVERY TEN MINUTES FOR ONE HOUR FOR A MAXIMUM OF 2400 RPM. DURING EACH INTERVAL, THE SAMPLE WAS OBSERVED FOR ANY RUNNING SOUND ANOMALIES. NO SOUND ANOMALIES OR ABNORMALITIES WITH THE FUNCTIONALITY WERE OBSERVED DURING THE TEST. A RETENTION SAMPLE FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION WAS OBTAINED. THE SAMPLE WAS RUN THROUGH THE SAME TEST AS THE RETURNED SAMPLE. NO SOUND ANOMALIES OR ABNORMALITIES WITH THE FUNCTIONALITY WERE OBSERVED DURING THE TEST. THE SQUEALING SOUND COULD NOT BE REPLICATED; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING ISSUES. 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, THERE WAS A SQUEALING NOISE COMING FROM THE PUMP. IT HAD BEEN PRIMED FOR ONE DAY AND HAD CIRCULATED FOR A SIGNIFICANT AMOUNT OF TIME. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699434 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ164275X UH28

    Patients

    Seq Age Sex Outcome Treatment
    1