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 500AVHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2022 |
Event Type
malfunction
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Event Description
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The service repair technician (srt) reported that during testing of the device at the service center, the venous blood parameter monitor (bpm) probe failed measured temperature accuracy testing.There was no patient involvement.
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Manufacturer Narrative
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Per the srt, during oven testing the bpm was reading 14.9 degrees celsius at 30 degrees celsius which was outside of the specification range.There were also various other inaccurate measurements at different temperatures.The srt replaced the venous bpm probe.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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Search Alerts/Recalls
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