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Catalog Number MX934Z4LM |
Device Problems
Crack (1135); Insufficient Flow or Under Infusion (2182)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 05/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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See mfr: 3012307300-2018-02321.
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Event Description
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It was reported that the second manifold, a medex¿ manifold, after 2 to 3 hours, of use also had cracked at cap side connection.Intravenous fluids and vasopressors leaked all over the bed and patient had loss of hemodynamic vitals.Patient had to be placed into trendelenburg position again with increase of drops (gtt).It was reported that there was no patient injury associated with this occurrence.
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Manufacturer Narrative
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One used manifold was received for device evaluation.Visual inspection revealed a crack at the female luer of the stopcock body.Based on the available reported information, it was determined that the crack was likely caused by prolonged exposure to drug/medications.This product is not designed to be impervious to all drug/medications or combinations thereof.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
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Search Alerts/Recalls
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