ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 1468728 |
Device Problems
Particulates (1451); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2023 |
Event Type
malfunction
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Event Description
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The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch in which the customer reported that foreign matter was observed in the drip chamber.It was not reported that if there was patient involvement; no harm was reported as a consequence of this event.
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it is yet to be received.Initial reporter- ext.(b)(4).
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Manufacturer Narrative
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One used device was returned for evaluation on 3/20/23.As received, a black spot was confirmed visible in the drip chamber.The drip chamber was cut open and the particle was confirmed to be embedded in the drip chamber wall, not in the fluid path.The area of the particle failed the allowable surface area of embedded material.The reported complaint can be confirmed.The most probable cause is burnt material embedded in the wall of the drip chamber during the molding process.The embedded material is not in the fluid path, and does not affect the functionality of the device.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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Search Alerts/Recalls
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