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
Invalid Sensing (2293)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded this complaint is related to cr-(b)(4) / medwatch #1828100-2018-00154.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial blood gas (abg) values were not matching.No other details regarding the nature of this event were provided.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed the monitor to pass startup self-diagnostics with no errors.
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Manufacturer Narrative
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Correction/removal number: 1828100-08/09/2010-004-c-500.The reported complaint could not be confirmed.Per central engineering 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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Further information was received that the surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a lung transplant using the heart lung machine (hlm), a procedure in which the perfusionist was flooding the field with carbon dioxide co2, the blood parameter monitor (bpm)did not track/trend all the values vs.Blood gas analysis (bga) as the perfusionist expected.On (b)(6) 2018, the perfusionist set up and calibrated her bpm shunt sensor correctly with gas a and gas b, along with placing the potassium (k+) code in the bpm.The perfusionist states that due to the nature of these long cases, it is difficult to pinpoint exactly where the bpm started not trending as expected.The team does not expose their shunt sensor until 50 meq of sodium bicarbonate is added to the plasmalyte - a solution.The manufacturer's clinical specialist spoke with the perfusionist about isolating the sensor completely from the circuit until initiation of bypass to preserve the chemistries in the sensor.Secondarily, the change in temperature was not known for this procedure.The team monitored the difference with additional arterial blood gas (abg) and continued the procedure with the same shunt sensor and monitor.The incident did not delay the continuation of the surgical procedure.There was no blood loss nor harm associated with the event.
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