Model Number HEMCSM10 |
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 02/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that there were inaccurate blood pressure readings that displayed with the clearsight module.During patient use.The system monitoring equipment was setup by the edwards representative.The patients blood pressure reading when monitoring the nibp was systolic 240.The radial arterial line reading was systolic 220.The aiq cuff blood pressure reading was systolic 130 to 150.The edwards representative was present and asked to recycle the bp.The patient placement for all three were on the same extremity, right arm.The procedure was a cea.During the procedure there was squirting of blood from the carotid artery.The blood loss quantity estimation is 200ml.There was no treatment for the blood loss.The patients post operative condition was fine,.There was no patient harm or injury.There was no inappropriate patient treatment administered.Patient is female, no other demographics available.The rep received a replacement clearsight module and used it for another case and there were no further issues.
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Manufacturer Narrative
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The device has been requested for return for evaluation, but has not yet arrived.When the evaluation has been completed and the findings available, a supplemental submission will be sent with the results.The device service history record review was completed and all manufacturing inspections passed with no non conformances.There were three other incidents with this same clearsight module that occurred at the hospital.Those incidents will be submitted separately in an mdr.The submission numbers will be sent in a supplemental follow up report when available.
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Manufacturer Narrative
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The product has been requested for return, but has not arrived.Once the product has been returned and the product evaluation completed the findings will be submitted in a supplemental submission.There are four occurrences with this same clearsight module.The mdr submission numbers to link them are; 2015691-2023-11283, 2015691-2023-11284, 2015691-2023-11286, 2015691-2023-11287.
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Manufacturer Narrative
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The module was returned and received for product evaluation.The unit was connected to a known good working hemisphere instrument for testing.There were normal blood pressure readings and a normal waveform that occurred.The system was left to run for 30 minutes and the readings remained stable.A visual inspection found no damage to the unit.The reported issue was not confirmed.
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Search Alerts/Recalls
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