General information: we received a complaint about a malfunction of a filter retention plate.Up to now, the product is not available for investigation.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Investigation: up to now, the product is not available for investigation.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.For further investigations, the product is required for examination.Rationale: according to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.Check all components of the sterile container visually for damage and correct function before every use.To ensure a safe use, instructions for use c48381 must be followed under all circumstances.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.
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