The customer¿s report that two pumping segments ballooned was not confirmed.The 2 used suspect primary sets that were in use at the time of the customer event were not returned for investigation.Received were 742 unused packaged associate sets with the following lot numbers: 19046410 (suspect lot number), 19046194, 19065143, 19056955, 19046440, and 19046734.Functional testing of a random sample of the returned sets did not replicate the bulge/balloon in the silicone segment of the tubing.Pressure testing also found no anomalies with the returned sets.The probable cause identified from previous extensive failure investigations have found that bulge/balloon could occur when an iv push medication or flush was executed below the pump without clamping the tubing above the injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to balloon.The root cause of the customer¿s experience was not identified because no balloons were replicated during functional testing.
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