TERUMO CARDIOVASCULAR SYSTEMS CORPORATION OVERPRESSURE SAFETY VALVE; VALVE, O.P.S. BULK, N-S
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Model Number LN130B |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/16/2016 |
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 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.Further inspection found that the duckbill valve would not open when under pressures within product specification.The device was then overpressurized above the product specification range, and a slow flow was eventually achieved.Using an ultrasonic knife, the sample was cut open and the duckbill valve was removed.The duckbill valve was squeezed, as it would have been in production to confirmed the existence of a slit, and it was found to still not open.After additional manipulation to the duckbill valve, a slit was eventually produced; however, it was not completely across the intended surface space of the valve.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 during cardiopulmonary bypass the overpressure safety valve did not allow forward flow.This event was initially deemed not reportable on october 20, 2016; 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.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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