ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Model Number 42800-03 |
Device Problem
High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Event Description
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The event involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, macrodrip.The device was reading a high pressure on the patient that did not correspond to readings on a blood pressure cuff.The reporter did not know if the patient received incorrect treatment based on the inaccurate readings.There was patient involvement, but no patient harm was reported.This is the second of two reported incidents.
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Manufacturer Narrative
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The sample has been requested from the customer for evaluation.However, it has not yet been received.
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Manufacturer Narrative
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The reported complaint of inaccurate readings was not confirmed.No sample or videos were returned.However an image was provided by the customer showing the label of the product.A failure mode was not able to be identified from the image provided by the customer.Without the return of the reported sample, a probable cause cannot be identified.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.D9: sample availability was changed from "yes" to "no" as customer did not return sample for evaluation.
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Search Alerts/Recalls
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