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Model Number E401000-10 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
Headache (1880)
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Event Date 11/23/2016 |
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.Upon completion of the investigation; a follow-up report will be filed.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.(b)(4).
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Event Description
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Halyard received a single report that referenced two different incidences, which were associated with separate units, involving a single patient.This is the first of two reports.Refer to 2026095-2017-00004 for the second event.Fill volume: 500 ml, flow rate: 100 ml/hr, cathplace: iv.It was reported that the infusion occurred in 2.5 hours to 3 hours on the first day and then 3 hours to 3.5 hours on the second day.The pump should have lasted for 5 hours.It was noted that good usage practices were observed by an independent nurse and the patient.It was also noted that the patient experienced headaches.
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Manufacturer Narrative
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The device history record of the reported lot was reviewed.According with the results the production lot met all manufacturing and quality specifications.All information reasonably known as of 10-apr-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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Search Alerts/Recalls
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