AVANOS MEDICAL INC. HOMEPUMP C-SERIES ELASTOMERIC PUMP, 60 ML, 2 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR
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Model Number C060020 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Hallucination (4428); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 20073483, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 09-jun-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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Event Description
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Fill volume: 30 ml.Flow rate: 2.5 ml/hr.Procedure: unknown.Cathplace: subcutaneous periumbilical region.It was reported, the ketamine infused in 2-hours instead of 12-hours.The infusion was started at 8pm and stopped at 10pm.The patient did experience symptoms of hallucination, tachycardia (110/beats per minute), high blood pressure and strong sedation.There was no reported injury, the patient is "ok." the side effects disappeared during the following morning.No additional information was provided.
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Event Description
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Additional information received 01-jun-2022 stated the high blood pressure reading was 170/90.
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Manufacturer Narrative
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Additional information b5.All information reasonably known as of 29-jun-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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