TERUMO CARDIOVASCULAR SYSTEMS CORPORATION OVERPRESSURE SAFETY VALVE; VALVE, O.P.S. BULK, N-S
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Model Number LN130B |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Visual inspection was performed on the actual sample, during which no anomalies were noted.A review of the device history records revealed no manufacturing issues.The actual sample was pressure and flow tested by pressurizing the unit with air and submerging the sample into a water bath.The unit was found to fail the forward flow test, not allowing flow through the duckbill valve within the device.The device was then pressurized above the product specification range, and a slow flow was able to be achieved.Although additional evaluation of this failure mode is being performed, it is currently believed to be a result of a process change at the duckbill supplier.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular systems corporation that just prior to cardiopulmonary bypass, the overpressure safety valve was defective.It was detected before ecc while an aspiration test was being completed.This event was initially deemed not reportable on march 6, 2017; however, terumo has issued a voluntary safety alert, 1124841-06/25/2017-001-c, on june 25, 2017.This event has become associated with the safety alert and has since become reportable.No known impact or consequence to patient.Unknown if product was changed out.Surgery was completed successfully.
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Manufacturer Narrative
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(b)(4).The investigation results and conclusions, previously reported, remain the same.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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