Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Liver Damage/Dysfunction (1954); Pain (1994); Thrombosis (2100); Weakness (2145); Heart Failure (2206); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Irritability (2421); Sweating (2444)
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Event Date 05/21/2018 |
Event Type
Injury
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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 consumer regarding a patient who was receiving morphine at an unknown dose and concentration via intrathecal drug delivery pump.The indication for use was noted as spinal pain.It was reported that the pump surgery caused the patient to be placed on oxygen, go into heart failure (her heart was okay as of (b)(6) 2018, per the patient), experience blood clots in the lung, and she had a fatty liver now.The patient needed to get the pump increased because she was still in pain and it was not helping.They had not put her on the right level yet.The patient thought she may be going through withdrawal and needed something for breakthrough pain (event date for withdrawal/breakthrough pain was last week, relative to (b)(6) 2018).There were no further complications reported at this time.Additional information was received from the consumer via a company employee (b)(4) 2018.It was reported the patient had been unable to see their managing pump doctor.It was reported the patient was starting to go through withdrawal because they were not getting their pump filled.The patient was worried that they were about to have a stroke.
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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 a consumer.The patient did not have a physician after the pump was put in, so it had not been increased like it should.The patient was not given oral to replace medications until the pump could be increased.The patient had been given a prescription by a doctor.An hcp wanted to give the patient injections.The patient was worsening abdomen pains.The patient had a doctor they were trying to get in with but did not have one now.Per the patient the hcp has not ordered or even knows the ¿level¿ and thinks the patient was where they need to be.Autoimmune has made morphine a go for the patient.The patient needs oxycodone or dilaudid in the pump.A physician gave the patient lyrica and butrins 15 mcg but the patient needs more or different plus the pump.The patient called a physician.The patient wanted to get the morphine stopped as it caused whelps and hives to suffer.The patient had problems with morphine before.The patient needs dilaudid or oxycodone in the pump.The patient indicated they were not understood (from tbi in the past- blood right frontal love.The patient was so sick and tired and worn out.The patient had whelps that come up and burn and itch from (b)(6) 2018.Increase 10% still low dose.The patient was scared to get an increase in morphine.The patient would sweat when they stand up and was tired all the time and irritable from continual pain worsening from before they got the pump.The patient was in more pain with breakthroughs.The patient did not have oral medication that the doctor said he planned to do while increasing the pump.The hives were so bad after the last increase and had become regular continually driving the patient crazy.The patient went to the hospital emergency room for a shot for hives but it did not work; cortisone does not work.
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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 patient.The patient reported they were so weak and dripping in sweat.The patient reported this past week they almost died from pain med withdrawal." the patient's blood pressure was 165/90, and they had an allergic reaction to the morphine.No further complications were anticipated/reported.
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Search Alerts/Recalls
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