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Model Number 13827 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2021 |
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 for additional evaluation or investigation.This issue was confirmed to be related 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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Sales representative contacted technical solutions to report a pocket fill.Representative reported that the patient was being refilled by a home infusion nurse, who realized that they had filled the patient's pocket with 20ml of drug.The nurse called the patient's managing physician, who guided them through aspirating the pocket.The nurse was able to get 12ml of drug back after aspirating.There were no immediate patient effects following this pocket fill, but the patient was brought to the emergency room immediately for treatment and was put on an iv.The patient's pump reservoir was drained and the pump was programmed to 0mg/day rate.A week later, the patient's pump was refilled in the office.The physician's plan is to monitor the patient, and after the next refill, the patient will be transitioned back to home care.
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Search Alerts/Recalls
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