TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TCM II HEATING AND COOLING SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
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Model Number 4415 |
Device Problems
Degraded (1153); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint is linked to emdr 1828100-2016-00159.Complaint is linked to emdr 1828100-2016-00213.The reported complaint was confirmed.The fsr found that the black heater hoses in the unit were deteriorating and needed to be replaced.The hoses were replaced and the debris was cleaned out of the unit.The fsr completed the preventative maintenance (pm) and 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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It was reported that during the use of the device for a non-clinical activity (the repair for medwatch #1828100-2016-00159 and #1828100-2016-00213), the field service representative (fsr), discovered black pieces of hose debris in the water of the cooler heater unit.There was no patient involvement.
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Search Alerts/Recalls
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