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 09/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Per the perfusionist, they were about 60 minutes into a cpb procedure when some of the measured values on the bpm went missing and displayed an error.The perfusionist turned the unit off, replaced the sensors, then restarted the unit.It was then that the arterial numbers were larger than expected, and the venous numbers were different than where they were previously.The data collection system never resumed pulling the bpm data and the data had to be manually entered.
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Event Description
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It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) was not sending data to the data collection system.Upon replacing the sensors and rebooting the system, the arterial measured parameters were larger than expected, and the venous measured parameters were also different than where they were previously.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was not verifiable since the product was not returned for evaluation or testing.The device was not returned as the user facility continued to use it with no further issues.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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Manufacturer Narrative
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Updated block: b5.
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Event Description
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Per clinical review: on (b)(6) 2021, the team experienced a problem with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure.They reported that the unit stopped sending data during the case.The end user proceeded to turn off the unit, replaced the sensors, and restarted the unit and it functioned as normal.The procedure was completed successfully with no delay, no blood loss, and no change-out.
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