ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Catalog Number 011-42584-05 |
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 03/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The customer has lost the sample so there was no product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.Additional information was received by the customer 5/24/2022 updating the occurrences from 1 to 4.Based on the updated occurrences the due date for this report is 6/23/2022.
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Event Description
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The event involved a transpac® iv monitoring kit, disposable transducer, 3 ml squeeze flush, macrodrip.The customer stated while this device was being used on the patient, there was inconsistency of pa and nibp values.The inconsistency of the pa and nibp values: 2 to 4 points compared to the nibp with correct curve.The drug involved was a physiological serum.There was no physical defect noted on the device.There was a one hour delay in therapy.There was no report of blood loss.The customer stated that the therapy was not completed, therefore the medical intervention provided was changing the sensor.The patient's condition before, during and after the incident remained the same.There was a delay in therapy and patient involvement, however no report of patient harm.Additional information was received on may 24th from the customer stating there was 4 occurrences.This captures 3 out of the 4 occurrences.
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Search Alerts/Recalls
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