ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Catalog Number 46100-91 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2023 |
Event Type
malfunction
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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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Event Description
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The event involved a cath lab w/5 port "off" manifold (600 psi), 72" admin set and 4 ft transpac® iv where the customer reported that a set was leaking and connections were not secure.The customer further stated that the products were cracked, and fluid sprayed out the side of the connection to transducer when connected to pressure and fluid.There was patient involvement but no harm was reported as a consequence of this event.This is report one of two.
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Manufacturer Narrative
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The reported complaint of a leak and connections would not secure was confirmed.During visual inspection, cracks and crazing near the cracks was observed on the female luer on both ends of the manifold.The returned set was primed and pressure leak tested and leaks were observed from the crack of the female luer on both ends of the manifold.The probable cause of the crack and crazing around the crack had occurred due to environmental stress cracking during use.The dhr for lot number 13672865 was reviewed and there were no relevant non-conformances found.
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Search Alerts/Recalls
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