TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT
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Model Number 809810 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The issue was discovered when the user facility was cleaning the unit.Per field service representative (fsr), verified the reported complaint.The blue wires in the heater on channel a are open.Replacements parts are no longer available, therefore no parts will be replaced.The user facility opted to continue to use the unit on channel b.
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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 heater cooler displayed an e08 alarm.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.Per field service representative (fsr), channel "a" failed but channel "b" operated to the manufacturer's specifications.There will be no parts to be returned, because removing the failed heater would disable the unit.The parts needed for repair are obsolete.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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Search Alerts/Recalls
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