AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR
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Model Number C270050 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 09-apr-2024 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.H3 other text : device not returned.
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Event Description
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Fill volume: 243 ml flow rate: unknown procedure: mastopexy surgery with implants device placed: (b)(6) 2024 cathplace: unknown it was reported the pump was installed with pain control medication for 5-days of treatment (120-hours), with a total volume of 243 ml.At approximately 91-hours of treatment, the device was almost finished (remaining volume compatible for about 5-hours of treatment).The treatment was scheduled for 120-hours but lasted approximately 96-hours.The clinicians recalculated the drug dosage and changed the infuser to complete the days of treatment.The patient was reported to be stable.There was no reported injury.
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Manufacturer Narrative
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All information reasonably known as of 29-apr-2024 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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Additional information received 12-apr-2024 stating "medications being infused via the pump included tramadol, ketorolac, dexamethasone and ondansetron.Administration occurred at the patient's home.The tubing was secured outside of the patient's clothes and the flow controller was taped to the patient's skin.The tube and flow controller were attached to the patient's skin with tape.
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