It was reported that during use, when it came time to purge the tubing, the device went into occlusion alarm.Troubleshooting was performed but the issue persisted.There was approximately one hour of time lost, 10ml of reconstituted product, 5mg of morphine, stress for the patient, and disturbance of other colleagues to find a solution.Per the reporter, there were no adverse patient effects.No new medical treatment was prescribed following the incident and the patient continued to take the usual long-term treatments.
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
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