The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer reported that at approximately 4:30 the pump was started per usual for a feeding.The distal line was occluded, resulting in a spillage of formula.This is not a first-time occurrence, it happens all the time if the distal end is occluded by clamping.When tested in a test environment it occurs at least 75% of the time.Additional information received stated the leaking occurred at the distal tip of the feeding set.
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