AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF
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Model Number CB004 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 11-dec-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
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Event Description
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Fill volume: 400 ml, flow rate: 8 ml/hr, procedure: unknown, cathplace: unknown.It was reported via fda medwatch mw5081190: "onq pump filled with ropivacaine 0.2% 400 ml x2.Pumps dispensed on (b)(6) 2018 at around 1000.Orders profiled in computer as 8ml/hr or each pump on 2018 at 1100.Pt's rn stated that the pump on the right side was empty.Surgeon was made aware and clamped the pump.Lot number of the clamped pump is 02083660.Date of use 2018.Is the product compounded? yes.Is the product over the counter? no." no patient injury reported.
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