The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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An evaluation of the kangaroo pump was performed and the customer states ¿the unit has no alarm.¿ the unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2017 and was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
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