Model Number 8637-20 |
Device Problems
Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)
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Patient Problems
Abdominal Pain (1685); Chest Pain (1776); Pain (1994); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: non-healthcare professional.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 consumer regarding a patient receiving morphine at unknown concentration and dosage via an implantable infusion pump for the treatment of post lumbar laminectomy syndrome and spinal pain.It was reported that the patient heard non -critical alarm about 3 weeks prior to the time of the report and hen had been hearing critical alarm for 2 weeks.The patient went to the patient's office and was told the drug was expired and the clinic was "closing their doors".The patient's pump was out of morphine.No further complication was reported.
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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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Additional information was received from the hcp.It was reported that the patient was supposed to get the pump refilled on monday but "the morphine was expired".The patient was told to go back on wednesday and then thursday.The patient couldn't get the pump filled on both days since the doctor was not there to authorize it.The pump had been completely empty for 2 to 3 weeks and had been alarming.The patient was in the emergency room at the time of the call.No further complication was reported.
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Manufacturer Narrative
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(b)(4).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 a consumer via a company representative.The patient missed a refill and their pump was dry.The event/difficulty was noted as having occurred on (b)(6) 2018.The event occurred during normal use.It was further reported that the patient came to the emergency room (er) with abdominal and chest pain.The patient had already gone through withdrawal symptoms.The patient¿s pump was passed the refill date and was alarming in the morning every 10 minutes.The patient¿s managing physician¿s office was closed, and the patient had been unable to find a new pain management physician to fill her pain pump.The pump was right out at the time of the meeting.The pump was further described as having been in fact empty and a critical alarm was occurring.There was no doctor on staff trained to fill the pump there and the clinical specialist silenced the alarms, reset reservoir, and ran the pump at minimum rate.It was noted that the clinical specialist advised the patient to find the company representative; entering physician as soon as possible to fill the pump.The issue was not resolved at the time of the report.The pump remained implanted/ in service.No surgical intervention occurred, and no surgical intervention was planned.The pump was noted as having delivered dilaudid.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.The patient¿s weight was provided.The patient¿s medical history was indicated as having been requested but was unknown.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: this field previously indicated only product problem in error.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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