ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ICP KIT FOR YALE-NEW HAVEN HOSP.; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Catalog Number 460690433 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2024 |
Event Type
malfunction
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Event Description
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The event involved a icp kit for yale-new haven hosp where the customer reported that the external ventricular drains (evd) noted to be leaking to bed linen.Neurosurgery notified to assess and change evd catheter.The patient has an anterior and posterior evd.The patient was on 7-3 neuro floor during the day and noted to have no drainage from anterior evd.Anterior evd was manipulated and changed.The patient was a renal replacement therapy (rrt) to pediatric intensive care unit (picu) after manipulation for q1hr neuro checks and evd management.The reporter observed that there was a small amount of drainage on the bed distal to the insertion site and proximal to the drainage chamber near the first 3-way stopcock.The reporter placed a paper chuck pad down to assess if the evd continued to drain into the linen.The resident then contacted neurosurgery and neurosurgery assessed at bedside.It was further stated that the reporter replaced the white paper chuck, but it was noted that the new white paper chuck was wet and assessed the evd catheter site closer.There was a cut/alteration to the catheter above the stop cock.The reporter then clamped the catheter with green kelly clamps.At 0000, it was noted that the evd was draining appropriately to the chamber.The case was done in npor.There were no charges for the external drain on there nor the icp kit.There was patient involvement; no harm was reported as a consequence of this event.
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Manufacturer Narrative
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The device has been received for evaluation, however, investigation is not yet complete.
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Manufacturer Narrative
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The reported complaint of separation was not confirmed on the returned sample.An image was provided by the customer showing a separated catheter.During visual inspection of the returned sample, unknown piece of catheter was received.The list number provided by the customer does not match with the returned sample.Without the return of the entire sample, the complaint could not be confirmed.Lot history review a dhr lot # review could not be conducted because no lot number(s) was/were identified.
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Search Alerts/Recalls
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