Model Number 8637-20 |
Device Problems
Failure To Service (1563); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding a drug infusion device.The drugs being delivered were 400 mcg/ml fentanyl at 46.64 mcg/day and 30 mg/ml morphine (unknown) at 3.498 mg/day.The reason for use was non-malignant pain and radiculopathy.It was reported that there was an empty pump alarm occurring.The rep had access to the patient and an 8840 clinician programmer.The patient missed a refill.The caller stated that the patient was not able to get the pump filled due to an insurance issue.The patient had been getting filled by pentec, and the patient relocated and found a physician to manage their care and pump moving forward.The hcp would like the alarms silenced.The pump alarms were silenced, the pump was updated to a full reservoir at minimum rate.The event date was listed as (b)(6) 2017.The patient was going to be referred to a surgeon for a pump replacement.There were no symptoms reported.There were no further complications reported/anticipated.
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Manufacturer Narrative
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Additional information indicated that the patient was referred to a surgeon for explant as the device was near end of life.The event is no longer reportable for serious injury, it is reportable for device malfunction.Included 'adverse event <(>&<)> product problem' updated to 'product problem'.'intervention required' no longer applies.'serious injury' updated to 'malfunction'.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the rep on 2018-apr-30.It was reported that the pump alarms were ordered off per the physician.The patient is being referred for pump replacement, as the pump is near end of life.The managing physician information was provided.There were no further complications reported/anticipated.
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Search Alerts/Recalls
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