TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.
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Model Number 809810 |
Device Problem
Insufficient Heating (1287)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is related to emdr #1828100-2016-00564.Per the biomed, the water in the unit was not cloudy or discolored, they use fresh filtered water and a.22 micron filter every day that the heater cooler is to be used and the leakage current was very high on both channels.The reported complaint was confirmed.Water was completely drained from the unit before the field service representative (fsr) arrived.Due to the observations of the biomed (manufacturer trained), the fsr did not test the unit or refill the water.The fsr replaced channel a heater and installed new heater o-ring.The fsr took the unit to the operating room (o/r) and refilled with filtered water and ice, then returned to the biomed shop and fully tested the unit with release testing.The fsr performed additional heating and cooling cycles.The unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned to the manufacturer.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 use of the device for a cardiopulmonary bypass procedure, the heater cooler unit was not heating on channel a.Error "e0a" was also observed on the unit.As a result, an alternate device was employed they continued with case.The surgical procedure was completed successfully.There was less than a five minute delay.No blood loss nor adverse consequences to the patient.Per the clinical review on 29-jul-2016: according to the user facility's biomedical engineer (biomed), the perfusionist (ccp) experienced an "e0a" error on the channel a.As a result, they opted to switch to channel b, but received an "e08" error (refer to emdr #1828100-2016-00564).Due to the malfunction of both channels, the user swapped out the unit for a back-up causing a delay of less than five minutes of heat exchange, but did not otherwise disrupt patient perfusion.There was no impact to the patient as a result.The case was completed successfully without associated blood loss.There was no harm observed.
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