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 500AHCT |
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 Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's sales associate, the issue had been occurring for a while.The user did not calibrate the bpm pre bypass, only on bypass using the blood analyzer.
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Event Description
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It was reported that during use of the device for cardiopulmonary bypass (cpb), the values on the blood parameter monitor (bpm) were inaccurate.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Event Description
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Per clinical review: on 05apr2022, the manufacturer was informed of a problem with the user facility's blood parameter monitor (bpm).The complaint was for inaccuracy, described as 'bpm results vary from last'.Per the manufacturer's sale associate, the issue had been going on since last year and had been occurring for a while on the unit.It was an old unit, and the user did not calibrate with gas a and b pre bypass, they calibrate on bypass with the istat.This issue occurred while on cardiopulmonary bypass (cpb).The unit was not changed out.There was no delay, no blood loss, and the procedures were completed successfully.
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Manufacturer Narrative
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Updated blocks: b5, d9, h3 and h6 during laboratory analysis, the product surveillance technician (pst) observed the monitor to boot up without any failures.Standard reference sensor (srs) and color chip testing was performed successfully.The pst used the bpm in factory default mode for calibration values.In operate mode, the monitor's on-screen values were adjusted to sample values successfully.The pst did not observe any sudden changes during sample operation.It was determined that the monitor functioned as intended.
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Manufacturer Narrative
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The reported complaint could not be confirmed.The service repair technician (srt) could not duplicate the reported complaint.The monitor powered on and passed self testing.The arterial blood parameter monitor (bpm) probe passed intensity testing and the hematocrit saturation (h/sat) probe passed service mode testing.The monitor passed all applicable testing.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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