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 05/20/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.The fsr found the buzzing was due to mineral deposits in diaphragm of the valve.The fsr cleaned the unit.The unit completed pm and was returned to clinical use.An 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 cooler heater unit, that a normally opened valve was making a buzzing noise.There was no patient involvement.
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Search Alerts/Recalls
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