SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 3SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET
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Model Number 2432-0007 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that as lvp 20d 3ss 0.2m cv tubing was loose and fluid was flowing out.The following information was provided by the initial reporter: material no: 2432-0007 batch no: 20075345.It was reported that there was an issue with the tpn tubing clamp.Verbatim: nch incident number: (b)(4).Can you describe the reported defect in detail? what happened? what was the cause? who was involved? bedside rn went to hang new tpn.Tubing used to spike new tpn bag.Immediately after spiking bag, fluid ran through tubing despite being clamped.Fluid was found to be flowing out mid-tubing, at the plastic clamp that is placed in the alaris pump channel.Can you provide the date(s) for the reported failure(s)? (b)(6) 2020.Was there any adverse event(s) as a result of the reported defect? if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.Yes initials: (b)(6) male, dob: (b)(6), prematurity.On (b)(6) 2020 patient did not get custom made tpn because of the tubing failure.
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Manufacturer Narrative
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H.6.Investigation: a complaint of clamp issues was received from the customer.One sample was returned for investigation.Through visual inspection two kinks were found on the set.One kink was found on the tubing between the pumping segment and the roller clamp and could not be smoothed out.The other was at the connection site of the third y-site.The set was then primed, and the safety clamp leaked through the top while engaged.The top of the clamp was then investigated with a microscope and a hole could be seen at the top of the clamp.A device history record review for model 2432-0007 lot number 20075345 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of clamp issues with lot #20075345 regarding item #2432-0007.The root cause for the first kink near the roller clamp was due to the design of the roller clamp.When too much force is applied when clamping it can kink or damage the tubing.The root cause for the second kink was due to the set being coiled and pouched prior to the solvent at the connection site fully drying.The root cause for the hole at the top of the clamp was error during the manufacturing process.
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Event Description
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It was reported that as lvp 20d 3ss 0.2m cv tubing was loose and fluid was flowing out.The following information was provided by the initial reporter: material no: 2432-0007 batch no: 20075345.It was reported that there was an issue with the tpn tubing clamp.Verbatim: nch incident number: (b)(6).1.Can you describe the reported defect in detail? what happened? what was the cause? who was involved? o bedside rn went to hang new tpn.Tubing used to spike new tpn bag.Immediately after spiking bag, fluid ran through tubing despite being clamped.Fluid was found to be flowing out mid-tubing, at the plastic clamp that is placed in the alaris pump channel.3.Can you provide the date(s) for the reported failure(s)? (b)(6) 2020.Was there any adverse event(s) as a result of the reported defect? if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.Yes.Initials: (b)(6), male, dob: (b)(6) 2020, prematurity.(b)(6) 2020 patient did not get custom made tpn because of the tubing failure.
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Manufacturer Narrative
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H6: investigation summary: a complaint of clamp issues was received from the customer.One sample was returned for investigation.Through visual inspection two kinks were found on the set.One kink was found on the tubing between the pumping segment and the roller clamp and could not be smoothed out.The other was at the connection site of the third y-site.The set was then primed, and the safety clamp leaked through the top while engaged.The top of the clamp was then investigated with a microscope and a hole could be seen at the top of the clamp.A device history record review for model 2432-0007 lot number 20075345 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 03jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of the defect.The root cause for the kink was due to the set being coiled and pouched prior to the solvent at the connection site fully drying.Improvements in the solvent application consistency in bonding process for external and internal engagements were performed.
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Event Description
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It was reported that as lvp 20d 3ss 0.2m cv tubing was loose and fluid was flowing out.The following information was provided by the initial reporter: material no: 2432-0007.Batch no: 20075345.It was reported that there was an issue with the tpn tubing clamp.Verbatim: nch incident number: (b)(4).1.Can you describe the reported defect in detail? what happened? what was the cause? who was involved? o bedside rn went to hang new tpn.Tubing used to spike new tpn bag.Immediately after spiking bag, fluid ran through tubing despite being clamped.Fluid was found to be flowing out mid-tubing, at the plastic clamp that is placed in the alaris pump channel.3.Can you provide the date(s) for the reported failure(s)? o (b)(6) 2020 ¿ was there any adverse event(s) as a result of the reported defect? o if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.) and date.Yes initials: (b)(6), male, dob: (b)(6) 2020, prematurity (b)(6) 2020 patient did not get custom made tpn because of the tubing failure.
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