TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
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Model Number 4415 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per the perfusionist, when the out valve was pushed in there was no water flow noting a possible scale and calcium obstruction.There were no fault lights indicated.The customer confirmed they descale the unit per protocol.The field service representative (fsr) was unable to duplicate the complaint.The arterial (art), cardioplegia (cpg) and blanket water lines were connected to the back of the heater cooler and the water flow was normal and strong.The customer was advised to descale the unit as sediment buildup could restrict the water flow.The unit operated to the manufacturer¿s specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass procedure (cpb), the heater cooler's flow was lower than normal.It was noted to take an unusually long time when checking the cooling and warming modes.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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