The actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which revealed that the device contained fluid inside the bladder.Due to the nature of the sample, no additional tests were performed.Based on the photo, the reported condition of under infusion was verified, however, the condition of leak could not be verified by the photograph.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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