The customer¿s report that there was a bubble in the pump segment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Yellow liquid was observed within the tubing from the drip chamber to the pump segment.At the top of the silicone pump segment tubing near the upper fitment, a balloon was observed.The balloon segment was measured to be approximately 1.5400 inches long and 0.7545 inches wide.Functional testing of previous complaints with the failure mode of ¿balloon/bulge in silicone tubing segment¿ was performed by placing the infusion set in an alaris pump module and closing the door, programming/running the infusion, pausing the infusion, and then injecting an iv push fluid bolus through a distal y-site of the infusion set.Ballooning was not replicated in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised (from previous ballooning).Further visual inspection of the silicone tubing¿s internal diameter observed to be concentric.The root cause for the source of the excessive pressure is unknown.
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