Model Number 2477-0007 |
Device Problems
Complete Blockage (1094); Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that as lvp bld180m 15d ss was difficult to connect.This causes damaged, flow issues, and leakage.The following information was provided by the initial reporter: material no.: 2477-0007, batch no.: 20045670.It was reported when connecting the male lure end of the tubing to a hot line, it requires more strength creating a sense that the connection is unstable or leading to over-tightening.The or have been experiencing some problems with bd tubing compatibility to the smiths medical tubing for the fluid warmers.The problem occurs with both the blood tubing and the pump infusion sets.When staff is connecting the male lure end of either tubing to a hot line, it requires more strength then they were otherwise use to, creating a sense that the connection is unstable or leading to overtightening (which inevitably means breakage or fused connections).Also, when connecting anything (secondary sets, micro infusion tubing), to the y-sites on the blood tubing or pump sets, it requires more strength to engage the valve then they were otherwise use to; in a situation where the connection is made loosely, flow is decreased and leakage occurs and in a situation where the connection is made using all their strength, overtightening occurs (which inevitably means breakage or fused connections).
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Event Description
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It was reported that as lvp bld180m 15d ss was difficult to connect.This causes damaged, flow issues, and leakage.The following information was provided by the initial reporter: material no.: 2477-0007 batch no.: 20045670.It was reported when connecting the male lure end of the tubing to a hot line, it requires more strength creating a sense that the connection is unstable or leading to over-tightening.The or have been experiencing some problems with bd tubing compatibility to the smiths medical tubing for the fluid warmers.The problem occurs with both the blood tubing and the pump infusion sets.When staff is connecting the male lure end of either tubing to a hot line, it requires more strength then they were otherwise use to, creating a sense that the connection is unstable or leading to overtightening (which inevitably means breakage or fused connections).Also, when connecting anything (secondary sets, micro infusion tubing), to the y-sites on the blood tubing or pump sets, it requires more strength to engage the valve then they were otherwise use to; in a situation where the connection is made loosely, flow is decreased and leakage occurs and in a situation where the connection is made using all their strength, overtightening occurs (which inevitably means breakage or fused connections).
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09/10/2020.Investigation conclusion: it was reported that there¿s connection issues with the set¿s male luer to a hot line.Received one new primary set model 2477-0007 lot 20045670.Also, received one used extension set model lot 20037349 and one used non-bd hotline fluid warming set.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies or damages were observed with the sets.Functional testing was performed by attaching the non-bd set to model 2477-0007¿s male luer.The non-bd set attached to the primary set without any difficulties, fully secured.The primary set was spiked to one lab iv bag filled with blue dye water to prime via gravity.The sets primed successfully and showed no signs of disconnects, leaks, or any issues.The primary set was detached and the non-bd set was attached to model mz9267¿s male luer.One 10ml lab syringe filled with blue dye water was attached to the extension¿s maxzero injection port.The syringe plunger was depressed gently and no disconnects, leaks, or issues were observed.The extension set was detached and the primary set was reattached to the non-bd set.The sets were then loaded into a lab pump module.An infusion rate was not provided, therefore the primary infusion was programmed at a rate of 125ml/h and vtbi of 125ml.The primary infusion completed with no alarms, disconnections, or any issues.The sets were pressure tested while submerged underwater (per dir # (b)(4) ¿ iv disposable leak test method).Air pressure was incrementally increased from 5 psi to 30 psi.No disconnections or leaks were observed at any of the set¿s components, connections, or throughout the sets.The sets¿ female/male luer ports were measured and found to be within iso standards with the female/male go/nogo gauges.Equipment used (measurement and testing performed on (b)(6) 2020).Air pressure regulator with pressure gauge, eq00151, calibration due date: 07nov2020.8015 alaris pcu 1.5, eq08330, calibration due date: (b)(6) 2021.8100 alaris system lvp, eq08327, calibration due date: (b)(6) 2020.Male go/no go gauge, eq08244, calibration due date: (b)(6) 2021.Female go/no go gauge, eq08248, calibration due date: (b)(6) 2021.A device history record for model 2477-0007 with lot number 20045670 was performed.The search showed that a total of (b)(4) units were built in 1 lot on (b)(6) 2020.The search showed that there were no quality notifications for the failure mode reported by the customer.The customer¿s report that there¿s connection issues with the set¿s male luer to a hot line was not confirmed.The root cause of the customer¿s experience was not identified because no disconnections, leaks, or any issues were replicated during functional testing.
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Search Alerts/Recalls
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