Model Number 550AHCT |
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 10/14/2021 |
Event Type
malfunction
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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 reading the temperature inaccurately.As a result, an alternate device was employed.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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Per the user facility's biomedical engineer, the arterial temperature was fluctuating around 24 degrees when patient temperature was 32 degrees.
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Manufacturer Narrative
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Updated blocks: b5, d9 and h3 h3 81: evaluation is in progress, but not yet concluded.
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Event Description
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Per clinical review: on (b)(6)2021, the team experienced a situation of temperature inaccuracy with the blood parameter monitor (bpm) during cardiopulmonary bypass (cpb).Per their biomedical engineer, the arterial temperature was reading around 24 degrees when the patient temperature was 32 degrees.The unit was changed out and the surgery was completed successfully, with no blood loss or delay.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) the monitor was powered up and put into operate mode.A multimeter with a temperature setting was set up with the probe fixed to the arterial (art) blood parameter monitor (bpm) in proximity to the thermistor.The art bpm was exposed to controlled temperatures along with the multimeter temperature probe and a comparison was made.The probe functioned as intended.The pst reviewed the erasable electronically programmable read only memory (eeprom) and there were no critical errors logged nor any standard reference sensor (srs) failure or color chip failures.
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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 issue.The arterial blood parameter monitor (bpm) probe was replaced as a precautionary measure.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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