ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. BIFUSE EXT SET W/2 MICROCLAVE, 2 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET
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Catalog Number B9092 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Phlebitis (2004); No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
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Event Date 11/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Plots 3732565 exp date 07/01/2023, 3744593 exp date 07/01/2023, 3702294 exp date 06/01/2023, 3744596 exp date 08/01/2023.Plots 3732565 mfg date 07/01/2018, 3744593 mfg date 07/01/2018, 3702294 mfg date 06/01/2018, 3744596 mfg date 08/01/2018.No product samples, videos, or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.The dhr for lots 3732565, 3744593, 3702294, and 3744596 were reviewed and there were no non-conformances found that would have contributed to the reported complaint.
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Event Description
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The event involved a bifuse ext set w/2 microclave, 2 clamps, luer lock that on an unspecified date, a leak was observed during an infusion of cytarabine, which was detected in the seal.There was an estimated loss of about 100ml.There was no harm reported.No additional information was provided.
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Event Description
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Additional information received.The event led to thrombophlebitis in the patient requiring a reinstallation of a heparin infusion catheter and infusion of heparin.
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Manufacturer Narrative
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It was initially reported the device was not being returned for evaluation.Additional information was received stating a sample is now available for evaluation.It has not yet been received.
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Manufacturer Narrative
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H10: one (1) used b9092 bifuse extension set was returned for evaluation.The distal male luer was separated at the bond.The bond was evaluated and found to have a solvent ring typical of a good bond, but no visible solvent adhesion in the area of the tubing to male luer bond interface.The probable cause of the bond separation is insufficient solvent coverage at the bond interface during manual assembly.Additional information in h3, h6h11: due to a system limitation, the date in g4 is inadvertently marked as 01/03/2019 in the supplemental emdr.The correct date is 03/01/2019.
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Search Alerts/Recalls
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