It was reported that a small volume infusor underinfused during infusion.The expected therapy time was 46 hours, however, after the infusion, there was still drug solution inside the bladder that had not infused to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Additional information was added to d9, h3, h4, h6, and h10: h4: the lot was manufactured between june 6, 2023 ¿ june 8, 2023.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported flow problem.A functional flow rate test was performed on the sample, and the flow rates were found to be within the product specification range.The reported condition was not verified.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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