As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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It was reported that approximately one-year post port device implant, the patient allegedly experienced pain during instillation or aspiration.It was further reported that after about two liters of blood removal the infusion machine alarmed for an occlusion and the clot was found in the extension tubing of the catheter therefore, tissue plasminogen activator (tpa) was administered.The treatment was completed with the femoral line access port.The physician reported that port was reassessed with no flow issues or fibrin development.The patient status is unknown.
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