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 Problem
Particulates (1451)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2022 |
Event Type
malfunction
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Event Description
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The event involved a primary plum set which was reported to have foreign matter found in drip chamber.It was not reported whether there was patient involvement or not, however, 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.
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Manufacturer Narrative
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One used list #14687-15, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #unknown was returned for evaluation.The reported condition of foreign matter found in drip chamber was able to be confirmed.Due to the size and crushed particles it was unable to be determined the type of the particles, however, it appeared to be grease.Probable cause was determined to be due to the molding manufacturing process because the grease is used in the tools as lubricants, and it could cause the particles.A lot history review could not be conducted because no lot number(s) was/were identified.Additional information a5 and a6; d9 - the device was received 5/20/22.
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