Model Number 2426-0007 |
Device Problems
Backflow (1064); Partial Blockage (1065); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
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Event Description
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It was reported from the surgical unit that there was a hole in the iv tubing set which resulted in fluids on the ground.Blood backflow was visible in the tubing and caused significant clotting in the midline and buff cap.There was no impact to the patient.
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Manufacturer Narrative
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The customer¿s report there was a hole in the iv tubing set which resulted in a leak was confirmed.Functional priming testing found the set leaked from the tubing above the distal smartsite port.No other leaks were observed throughout the set.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed allowing fluid to flow through the whole set by gravity, the set leaked from the previously observed cut in the tubing.The source of the leak is due to a cut in the tubing.The root cause could not be determined.
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Event Description
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It was reported from the surgical unit that there was a hole observed in the iv tubing set which resulted in fluids leaking on the ground.Blood backflow was also visible in the tubing and caused significant clotting in the midline and buff cap.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
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Manufacturer Narrative
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The customer¿s report that there was a hole in the iv tubing set which resulted in a leak was confirmed.Functional priming testing found the set leaked from the tubing above the distal smartsite port.No other leaks were observed throughout the set.The customer's report of blood backflow was not confirmed, however; the customer's experience is likely a result of the hole in the tubing.The set was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed by filling a lab iv bag with blue dye water and attaching it to the set allowing fluid to flow through the whole set by gravity.The root cause of the cut damage could not be determined.
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Event Description
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It was reported from the surgical unit that there was a hole observed in the iv tubing set which resulted in fluids leaking on the ground.Blood backflow was also visible in the tubing and caused significant clotting in the midline and buff cap.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
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Search Alerts/Recalls
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