A user facility in (b)(6) reported a blood leak that occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred at the bloodline connector.It was reported the blood leak occurred sometime in 2020, however an exact date was not provided.It was unknown how long into the patient¿s treatment the blood leak occurred and if there were any connection issues, defect, or damage noticed on the bloodline.Additionally, it was unknown if there were any patient symptoms, injuries, adverse events, or medical intervention required, or if the patient was able to complete treatment.Patient information, including estimated blood loss, was unknown.The complaint device was not available to be returned to the manufacturer for physical evaluation.Additional information regarding the event was requested, however was not provided.
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Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.As no lot number was provided for this complaint, a product delivery history search (for the 2020 year) was requested.The pharmacovigilance specialist for fmc mexico provided the delivery history search.Eight lots were found to have been delivered in this time period.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
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