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Model Number 13827 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Skin Discoloration (2074); Dizziness (2194); Discomfort (2330); Diaphoresis (2452)
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Event Date 03/03/2022 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device remains implanted and was not returned.Issue was determined to be a pocket fill due to user error.Per the instructions for use of the device, refill errors are known possible risks of use of the device.Internal complaint number: (b)(4).
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Event Description
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Nurse contacted technical solutions to report a pocket fill at a patient's last refill appointment.Nurse stated that the procedure went as usual, but after 30 minutes in the facility, the patient reported feeling uneasy.Nurse reported that the patient was diaphoretic, had flushed skin, and looked intoxicated and dizzy.The patient was taken to the hospital in an ambulance, but the patient walked to the stretcher.The patient was administered a dose of narcan.The patient was not admitted to the er and left to return to the facility and drove themselves home.The patient was feeling fine and was safe to manage themselves.At the next refill date, it was confirmed that there was a 1ml pocket fill.
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Search Alerts/Recalls
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