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Model Number E401000-10 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Nausea (1970); Pain (1994); Chills (2191); Dizziness (2194)
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Event Date 01/09/2017 |
Event Type
Injury
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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.Root cause could not be determined.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).Device not returned.
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Event Description
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Halyard received a single report that referenced two different incidents, which were associated with separate units, involving a single patient.This is the second of two reports.Refer to 2026095-2017-00018 for the first patient.Fill volume: 400 ml, flow rate: 100 ml/hr, procedure: unknown, cathplace: unknow.It was reported that the patient experienced an acceleration of infusion twice on the same day.The first device completed infusion in 3-hours instead of 4-hours.The second device completed infusion in 2-hours instead of 4-hours.The patient exhibited symptoms of feeling sick, dizziness, nausea, chills, and pain in the arms and legs.No further information was received.
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Manufacturer Narrative
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Describe event or problem - the initial report contained a reference to two patients.However, there was only a single patient with two events.The pump was received empty.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.When opening the pinch clamp infusion was observed.Flow accuracy testing was performed on the pump.After 3 hour of testing the pump yielded a flow rate of 75.15ml/hr which is below specification with a +/-15% tolerance.Pressure pot test was performed on the flow control tubing with the tubing detached from the pump.The tubing was connected to a pressure transducer using 8.42 psi.After 1 hour of testing the flow control tubing yielded a flow rate of 4.44ml/hr which is below specification with a +/-15% tolerance.The filter was removed from the tubing and pressure pot testing performed a second time.After 1 hour the tubing yielded a flow rate of 99.21ml/hr which is within specification with a +/-15% tolerance.The evaluation summary concludes that fast flow was not observed.The pump infused after refilling to nominal volume.Flow accuracy testing of both pumps was below specification.The first pressure pot test on the flow control tubing with the filter was below specification.After the filter was removed from the tubing of each pump pressure pot testing was performed a second time.The flow rate of the pump without the filter was within specification.It could not be determined what the filter occlusion was.Use review was conducted, it was concluded that the information provided does not suggest that the product was not used in accordance with the instructions, nor does user/ facility condition seem to be contributors to the incident.Regarding patient symptoms, based on the package insert of monurol, it was concluded that the drug fosfomycin filled in the pump could possibly be a contributor to the adverse events.Root cause is deemed to be unknown.According with the dhr review the production lot met all manufacturing and quality specifications.All information reasonably known as of 19-jun-2017 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 halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).
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Event Description
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Halyard received a single report that referenced two different incidents, which were associated with separate units, involving a single patient.This is the second of two reports.Refer to 2026095-2017-00018 for the first event.
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Search Alerts/Recalls
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