It was reported that the female connector of a minicap transfer set could not be disconnected from the patient line of a cassette.It was further reported that the patient tried to disconnect the transfer set from the patient line, but was unable to disconnect and the transfer set itself came apart.This occurred after use of the device for peritoneal dialysis therapy.To resolve the issue, the transfer set was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Correction made to e1: initial reporter phone no.: (b)(6).Additional information was added to d9, h3, h6 and h10.H10: the device was received for evaluation with a patient connector attached to the female connector.A visual inspection with the naked eye noted a separation between the female connector and main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The transfer set was connected and disconnected using the returned patient adapter with no issues.The reported condition of connection issue with the female connector was not verified, however, the condition of separation between the female connector and main body was verified.The cause of the separation was due to an inadequate solvent bond between the female connector, insert chip, and main body during the manufacturing process.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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