Additional information was added to d9, h3, h4, h6 and h10.H4: the lot was manufactured from august 24, 2020 - august 25, 2020.H10: the device was received for evaluation.Visual inspection was performed which observed that the tube set pvc (polyvinyl chloride) was detached from pump head assembly connector.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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