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 02/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported complaint was confirmed.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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Event Description
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The service repair technician (srt) reported that during testing of the device at the service center, the blood parameter monitor (bpm) failed temperature accuracy testing with a reading of 13.2 degrees celsius (c), which was below the minimum specification of 15 degrees c.There was no patient involvement.
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Search Alerts/Recalls
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