MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 3SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2432-0007

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: AS LVP 20D 3SS 0.2M CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11089095
• MDR Text Key: 238382009
• Report Number: 9616066-2020-20668
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232327
• UDI-Public: 50885403232327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/03/2023
• Device Model Number: 2432-0007
• Device Catalogue Number: 2432-0007
• Device Lot Number: 20075345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 12/07/2022
• Supplement Dates FDA Received: 01/15/2021; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Sex: Male