ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Catalog Number 011-46115-21 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/13/2023 |
Event Type
malfunction
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Event Description
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The event involved a transpac where it was reported that when flushing the hep saline there was leaking from where syringe safe set connects to the line.Blood then tracked back up the line to the safe set syringe.The issue was resolved by removing affected product from use.The root cause was identified and it was a faulty bonding in safe set.There was patient involvement but no patient harm.This captures 1 of 2 occurrences.
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Manufacturer Narrative
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The device is available for evaluation, however has not been received.
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Manufacturer Narrative
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Received one used.List #011-46115-21, transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port; lot #13612950.During visual inspection, 2" pressure tubing was received separated from the rotating male luer.When the end of the tubing was microscopically examined, insufficient adhesive coverage was observed.The probable cause of the 2" pressure tubing being separated from the rotating male luer had occurred due to insufficient adhesive coverage on the tubing during assembly when the rest of the set was primed and pressure leak tested, no leaks were observed around the safeset reservoir and the plug stopcock.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on (b)(6) 2023.
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