The suspect device has been returned for evaluation.Functional testing was performed.The complaint could not be confirmed due to no leakage was observed.The root cause could not be determined however, it is likely that all connections to the patient were not frequently checked by the attending medical staff/loose connection [use error].The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
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