ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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Catalog Number 425850405 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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One used list# 425850405, monitoring kit was received for evaluation.The reported complaint of "pressure tubing connection was leaking" was confirmed.No visual anomalies were observed.When primed and pressure leak tested, a channel leak was observed from the pressure tubing and the male luer.A pull test was conducted between the bonds through which a channel leak was observed.The tubing pulled off from the luer at 13.3 lbs which is above the specification limits of 6 lbs.When the bond surface of the pressure tubing was examined, insufficient solvent was observed on one side of the pressure tubing through which a channel leak was observed.The probable cause of the channel leak between the pressure tubing and the male luer had occurred due to insufficient solvent applied during assembly process.A device history review (dhr) for lot# 3981038 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
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Event Description
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The event occurred in the operating room and involved a transpac iv monitoring kit, 84¿ disposable transducer, 3 ml squeeze flush, macrodrip that during priming, the pressure tubing connection right after the flush device was leaking.The device was replaced.There were no obvious defects noted on the tubing and there was no mating device attached on the tubing.There was no serious injury, death or potential for death or serious injury, the product was not used on a patient at the time of the incident and there was no delay critical therapy when the problem was noted.
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