Device was returned for additional evaluation and investigation.A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Additional physical investigation was performed on the device, but the reported issue could not confirmed or denied.Visual inspection of the exterior of the pump did not show any anomalies.An attempt to inquire the pump failed.No tone was heard during the inquiry.An attempt to read the pump memory with the programmer terminal tool, failed.As the pump was unresponsive and could not be inquired, the memory could not be read and the presence of error codes 100 and 104 could not be confirmed or denied.Testing of the battery confirmed it only had 0.99 v, not enough to power and run the module.Neither error code 100 or 104 are attributed to low battery, and furthermore, error codes are not known to cause the battery to drain quickly.The root cause for the loss of battery power could not be determined.Internal complaint number: (b)(4).
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