TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 858828 |
Device Problems
Electrical /Electronic Property Problem (1198); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The srt replaced the arterial bpm.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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The service repair technician (srt) reported that during routine testing of the device at the service center, the arterial blood parameter monitor (bpm) failed high potential (hi-pot) testing.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the arterial blood parameter monitor (bpm) to be defective, the thermistor wire failed hy-pot 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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Search Alerts/Recalls
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