TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT
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Model Number 809810 |
Device Problem
Impedance Problem (2950)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As per srt, the heater cooler passed all functional testing with the exception of leakage current testing which failed.The replacement part is not available, so the unit was returned to the customer with a note included in the service report that it failed leakage current testing.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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The service repair technician (srt) reported that during routine testing of the device at the service center, the unit failed ¿reverse¿ leakage testing.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.Per the service repair technician, this is a non clinical unit that product development needs for testing and will be scrapped after the study.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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