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Catalog Number FS116 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Underdose (2542)
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Event Date 11/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Potential lot number: 3215639, potential expiration date: 05/28/2019, potential device manufacturer's date: 06/15/2016.The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).
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Event Description
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It was reported that a medex¿ micro bore extension set had leaking at the filter while in use on a patient.The patient did not receive all of the intravenous fluid and as a result, the patient was at increased risk of infection.The device was in place for up to 72 hours, based on standard tubing change practice.The tubing was replaced with a new set.No patient injury was reported.See mfr: 3012307300-2016-00484, 3012307300-2016-00485, and 3012307300-2016-00486.
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Manufacturer Narrative
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One medex¿ micro bore extension set was returned for evaluation.Visual inspection found that the device was in used condition.Functional testing involved a water leak test and showed that the returned device leaked at the center of the filter.A review of the inspection activity documents was deemed adequate.The indication for use (ifu) states that the device should be changed every 24 hours.Based on the evidence, the root cause is attributed to the use of the device inconsistent with its ifu.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.
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Search Alerts/Recalls
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