ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE; STOPCOCK, I.V. SET
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Catalog Number 011-CH3142 |
Device Problem
Particulates (1451)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available to be returned for evaluation; however, it has not yet been received.
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Event Description
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The incident involved a 43 cm (17") appx 6.9 ml, trifuse add-on set w/3 clamps (blue, 2 red), dry spike adapter.The reporter stated that after the nurses prepare their lines by attaching the spike to saline, then attaching the iv line, plastic is noted in the iv line chamber when priming with saline.The sets were not reprocessed or re-sterilized prior to use.There was no patient involvement, no delay in therapy, and no one was harmed as a result of the reported event.This is the second of two reports.
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Manufacturer Narrative
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A used sample #(b)(6) connected into a 0.9% sodium chloride 500ml bag and an unknown, extension set w/ drip chamber was returned for evaluation.As received it was observed a white debris floating inside the dry chambers.Inside dry spike adaptor a flash was observed.The sample was tested using a filtration system and plastic debris were found after the test.Complaint of particulate matter can be confirmed based in the physical sample returned by customer.The probable cause of the excess of plastic inside the dry spike adaptor was due an error during molding process from manufacturer¿s (ensenada) supplier.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 8-aug-2023.
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Manufacturer Narrative
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The complaint investigation was updated and re-summarized as follows: a used sample #(b)(4) connected into a 0.9% sodium chloride 500ml bag and an unknown, extension set w/ drip chamber was returned for evaluation.As received, white debris was identified floating inside the dry chamber.Flash was observed inside the dry spike adaptor.The sample was tested using a filtration system and plastic debris were found after the test.A computed tomography (ct) scan of the dry spike adaptor sample #2 was performed along with an fourier transform infrared spectroscopy (ftir) study of the plastic debris found during the filtration system test for sample #2.The ct scan showed no significant internal damage.The ftir results showed ir spectrum consistencies between the plastic debris and the adaptor.The complaint of particulate matter can be confirmed based in the physical sample returned by customer.No assignable cause related to icu medical product manufacturing or design was identified.The reported condition was replicated when using the drip chamber spike provided by the customer.The shape of this drip chamber used to access the icu medical dry spike is considered the most relevant factor to create these particulates.The probable cause of the drip chamber tip getting broken inside of the dry spike adaptor was due to unintentional bending force applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Updated information can be found in g1 and h6.
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