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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Fatigue (1849); Pain (1994); Hip Fracture (2349); Cognitive Changes (2551)
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Event Date 09/07/2018 |
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 healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving di laudid (8 mg/ml at 3.7502 mg/day), bupivacaine (6 mg/ml at 2.8126 mg/day), clonidine (200 mcg/ml at 93.75 mcg/day), and fentanyl (400 mcg/ml at 187.51 mcg/day) via intrathecal drug delivery pump.The indication for use was not noted.It was reported that the patient was very drowsy.The pharmacist and nurse at the patient's bedside on (b)(6) 2018 reported that the patient had not been very alert over the past 48 hours.The hcp refilled the patient's pump on (b)(6) 2018 in the hospital.The hcp requested pump infusion be reduced by 20%.The patient was not receiving any additional intravenous (iv) or oral pain medications.The patient's husband reported the patient fell on (b)(6) 2018 and had broken her right hip.The patient had hip replacement surgery over the weekend.The issue was not resolved and the patient was "alive - with injury." there were no further complications reported at this time.Additional information was received from the manufacturer representative.It was reported that it was unknown if the device/therapy caused, contributed to, or exacerbated the patient's fall and broken right hip.The hcp did not have an additional update on the patient's status as of (b)(6) 2018.There were no further complications reported at this time.
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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 via a manufacturer representative.It was reported that the patient had been discharged from the hospital to an extended care facility (ecf), having increased pain due to pump dose reduction.The patient was recently re-admitted for symptoms of a myocardial infraction (mi).It was not reported that the device had any cause, contribution to, or exacerbation of symptoms of the patient's mi.There were no further complications reported at this time.
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Search Alerts/Recalls
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