Note: product reference 4430095 is not cleared in usa, but it is similar to the product reference 5430095 cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.The sterilization records, the lal and bioburden test results were reviewed.All data are compliant with our requirements.No other similar complaint has been reported to us on this batch of access ports released in june 2020.Investigation: we did not received the complaint sample for investigation.No bacteriological test results have been communicated to us.Conclusion: the received elements do not allow us to conclude on the exact cause of the infection.However as our records shows that this batch of celsite access port has been manufactured, packed and sterilized in compliance with our specifications and validated processes, no other complaint were reported on this batch, we can deduce that this incident is not directly imputable to the device.The ifu gives some recommendations concerning access ports maintenance.The review of the customer complaints database does not show any increasing trend for infection following access port implantation.The global complaint rate for infection on celsite access ports is very low: 0,0006%.No corrective action is envisaged.
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On (b)(6) 2020, when the patient used the celsite for infusion, she developed cold intolerance and fever.Stopped using infusion port and used peripheral venous infusion instead.The patient was obviously improved.The crp and procalcitonin were significantly increased, and the possibility of bacteremia caused by celsite infection was considered.After the discussion of the department and the consultation of relevant specialists, applied anti-inflammatory treatment.On (b)(6) 2020, the infusion tube was taken out, and bacterial culture was carried out on the catheter, and the result was positive.After the operation, the patient continued anti-inflammatory treatment, and no fever or cold intolerance occurred.After reexamination, crp and procalcitonin decreased significantly, blood culture results were negative, and the patient was discharged smoothly after the condition improved.No sample or picture provided.
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