The event involved a ndehp pca set 86in that the customer reported a patient in the recovery room received a 6mg bolus of dilaudid.The customer stated the nurse used the pca tubing without the filter.The diagram they provided shows they used an extension set with a filter that has a 6ml prime volume attached to the end of the pca tubing.Hydration fluid was attached to the y site of the pca tubing.The hydration fluid was unclamped, which resulted in a flush of the extension set and the bolus of dilaudid.The patient spo2 decreased, vitals declined, and the patient became unresponsive.The patient received narcan a couple of times to reverse the effects of the pain medication.The patient ended up staying an extra day in the hospital.
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H10: no product samples or videos were returned for investigation.Images were returned which appear to show two different configurations of the same list number however the lot number was not provided for one sample.From the list number data, it is possible that the two sets are part of the same family of products and tuc (trades union congress) code, however not exactly the same list number.The full list number is 9 numbers, not the abbreviated list number seen on the package, the lot number would be required to verify this and it was unable to be retrieved.The complaint of differing sets cannot be confirmed without further information.A batch record review was performed to lot# 875725h, list# 14279-0489 and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.This lot was manufacture on 03/23/18.Manufacturing quality (mq) performed visual and physical evaluation with zero defects found.Maintenance routines and maintenance work orders (wo) were not analyzed, since there are no machines involved that could be associated to the defect reported.No process changes, unusual event, re-work, re-processing or re-inspection activities were generated or performed to the batch mentioned above or its commodities.As a result, no discrepancies that may have contributed to a complaint of this nature were found.
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