Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 01/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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User facility reported that the device was placed in use with patient for spinal anesthesia but the drug did not take effect.According to reporter, the procedure required general anesthesia due to this issue.No permanent adverse effects to patient reported.
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Manufacturer Narrative
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Twenty original sealed trays and (b)(4) original cases of product were returned for investigation.Ten samples were forwarded to the supplier of the anaesthesia medication for evaluation.The supplier performed visual examinations on the product and reported that they could not find any issues with the samples.The supplier preformed a complete review of their manufacturing records for the reported lot associated with the reported product issue.The supplier concluded that the bupivacaine met specifications at final testing.The supplier also tested retained samples for potency.All testing found the product to meet specifications with no degradation or loss of efficacy.Smiths medical forwarded (b)(4) of the samples to their accredited laboratory for potency testing.Potency testing was found within specification (b)(4) for all tested samples.Testing customer's returned samples and evaluating retain samples could not duplicate the reported product issue.As the reported product issue could not be confirmed through testing, an exact root cause could not be determined.Possible cause for the lack of effect may be related to administration technique or patient anatomical variations, including pathological or psychological factors.No corrective actions are planned at this time.
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Search Alerts/Recalls
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