TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS DUAL COOLER/HEATER SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS DUAL COOLER/HEATER SYSTEM
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Model Number 11160 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/09/2012 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.The fsr confirmed the noise as being one of the solenoid valves which needed cleaning.The valve was cleaned and was no longer noisy.The unit operated to manufacturer specifications and was returned to clinical use.A mdr remediation activity related to manufactured devices with a fda product code dwc: controller, temperature, cardiopulmonary bypass heater cooler" was conducted.This report is a result of the "heater" cooler response remediation protocol 02-jun-2016.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he discovered a noise from the cooler heater unit when set in cooling mode.There was no patient involvement.
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Search Alerts/Recalls
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