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 Date 05/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3: 81 - evaluation is in progress, but not yet concluded.
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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) hematocrit (hct) values 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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Manufacturer Narrative
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The reported complaint was confirmed.The service repair technician (srt) powered on the blood parameter monitor (bpm) and observed a failed self-test with a 'reference sensor test' failure, hematocrit (hsat).The hsat failed service mode testing exceeding the product specification limits.The srt replaced the hsat.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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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) connected the bpm to lab use only (luo) testing equipment.Upon power up of the bpm the erasable electronically programmable read only memory (eeprom) showed a f00d error.There were 32 color chip errors reported in the eeprom.The monitor was powered up in service mode and the hematocrit saturation module (h/sat) values were within expected range of operation, however the hsat failed to recognize the 1/2-inch cuvette.The hsat was opened to investigate the sensors that identify the different size cuvettes, and the pst observed the sensor was intact and engaged as required.It was determined that the failure was the recognition of the 1/2-inch cuvette.
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Event Description
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Per clinical review: on 26may2023 the team experienced a problem with their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb) described as inaccurate hematocrit (hct) values.The unit was not changed out, there was no delay or blood loss, and the procedure was completed successfully.
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