ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK; STOPCOCK, I.V. SET
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Model Number B55005 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problems
Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
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Event Date 02/04/2022 |
Event Type
Injury
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Event Description
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The event occurred in an intensive care unit (icu) and involved a 14" ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext.It was reported that a crack/leak was observed on the device when multiple pressors and sedatives had been infusing into the central line of a patient.It was noted that the product was used for less than seven hours when the event occurred.The patient¿s blood pressure decreased drastically, and a patient code resulted.Compressions were performed, the gang bar was replaced, and therapy resumed.There was patient involvement and patient harm reported.
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Manufacturer Narrative
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It is unknown if the device is available for evaluation.Although the device has been requested to be returned for evaluation, it has not been received.
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Event Description
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The customer provided the following additional information: the patient is female in her mid-50s with a systolic blood pressure (sbp) in the 140s leading to the event.Then, her sbp went down to the 80s.She increased levophed from 14 to 16, rider increased to 20.The sbp then went up to 120s.She decreased levophed back to 14, rider 10.The sbp then went down to 80.She increased the levophed back to 16 rider to 20.The sbp went further down to 60s.She increased levophed to 20, ride to 30.She eventually turned the levophed up to 24 and the rider up to 40.The sbp did not go up and was now in the mid 40s, and she called for help.The medication involved lumen 1 - nstkvo, lumen 2 - nstkvo, lumen 3 - levophed, vasopressin, propofol, fentanyl and rocuronium.
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Manufacturer Narrative
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Although the defective sample and sister samples were requested to be returned for investigation, there were no product samples returned.A photograph was provided showing a 14" ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext assembly.There were no defects or anomalies observed when examining the photograph that the customer provided.The device history record (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
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