ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.68 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 2 CHEC; STOPCOCK, I.V. SET
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Model Number MC33687 |
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 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
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Event Description
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The event involved a 4" (10 cm) appx 0.68 ml, smallbore trifuse ext set w/3 microclave clear, 2 check valve, 3 clamps (2 white, red), rotating luer in which the reporter stated that there was a leakage between the bonded needleless connector and the iv tubing.The leaking was observed at the bonded microclave, where the primary tubing is attached and the center of the needleless connector.The customer reported that there was a loose connection between the alaris iv tubing the fixated microclaves on the connector.Nurse described that norepinephrine (a vasopressor) was infusing through the line, during patient infusion/procedure and iv tubing leaked and disconnected from the microclave.There was patient involvement, but there was no reported harm as a consequence of this event.
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Manufacturer Narrative
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One open/unused device list #mc33687, 4" (10 cm) appx 0.89 ml, smallbore trifuse ext set w/3 microclave¿ clear, 2 check valve, 3 clamps (2 white, red), rotating luer; lot #7154218 was received for evaluation on 12/8/2022.There were no visual anomalies or damage observed.The used trifuse extension set was pressure leak tested at each of the proximal and distal connection points.No leakage was observed at any location or connection during testing.The complaint was unable to be replicated or confirmed during lab testing.The lot history of the provided sample was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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