Catalog Number 21-7091-24 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Fever (1858)
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Event Date 06/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Other, other text: g3:canada.D4: lot number, and expiration date is unknown.H4: device manufacture date is unknown, no information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported the disposable exhibited a leak at the connection where the pca line joins the primary line.Nurse noted air in line.Nurse disconnected the line from the patient to attempt to flush the air through.When flushed from the primary line the flush continued to the end of the line, but then drained back to the connection where the pca line joins and began to leak.Patient was newly febrile but stable, unknown if related.Patient was fully cultured and the defective line and ij remove.No adverse patient effects were reported by the customer.
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Manufacturer Narrative
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Other text: one sample was received for evaluation.Visual inspection revealed the sample was broken between the bonding of the asv valve and the y-site.It was observed that inside of the y-site remained part of the asv valve; they were bonded with solvent.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.No lot number was provided; therefore, a history record review could not be conducted.No action was taken.D3, g1, g2 email address: (b)(6).
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Search Alerts/Recalls
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