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Model Number 13827 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
Injury
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Event Description
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Clinical specialist (cs) contacted technical solutions reporting that 6ml were pulled from the reservoir after an mri.Technical solutions and cs attempted to troubleshoot, but the cs was unable to fully discern if they could hear the valves opening and closing due to the size of the patient.Cs then attempted to aspirate from the reservoir again to see if the valves had closed.This time, cs pulled back 3ml and stopped.At this point, the decision was made to inform the following physician about the valves and to re-evaluate at a later date as the patient was currently admitted in the hospital due to an unrelated event and was already on iv pain medication and was being observed closely.The patient had back surgery the day after the mri.The patient requested to explant the pain pump during the surgery, and it was explanted.
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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-conformance's, issues or capas associated with pump function.Device was not returned for additional evaluation and investigation.As the device was not returned for additional investigation, a definitive root cause could not be determined for the alleged issue.Internal complaint number: (b)(4).
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Search Alerts/Recalls
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