MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 36 IN 15 DROP SECONDARY SET W/HGR; INTRAVASCULAR ADMINISTRATION SET

Model Number MS3500-15

Device Problems Free or Unrestricted Flow (2945); Infusion or Flow Problem (2964)

Patient Problem Overdose (1988)

Event Date 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Date received by manufacturer: bd was initially made aware of this complaint on 2020-09-25.Additional information was later received on 2020-11-18 that changed the material information grid and caused the creation of this mdr.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 36 in 15 drop secondary set w/hgr had a check valve malfunction and was too full resulting in overinfusion.The following information was provided by the initial reporter: material no: pri tubing batch no: unknown.It was reported that the primary bag was found to be more full than the secondary resulting in an over infusion of vancomycin.Event description per email states: from bd rep: since the programming data does not seem to conclusively show the rationale for the vancomycin being delivered faster than intended, that is making me think beyond the programming.With xxxx stating that the primary bag looked fuller at the end, it makes me suspicious in wondering if there was a faulty back check valve on the primary tubing that lead to the retrograde flow of the secondary infusion contents into the primary bag.This one way valve should have prevented that, but if there is a bit of glue residue that prevents it from sealing completely, it can cause retrograde flow.I suspect the tubing is gone!?! if not, sending this in for testing by customer advocacy could validate this suspicion.Since this can be isolated to one tubing vs.A lot, sending in another tubing from the same lot would not necessarily help in this situation.I have spoken with our new biomed.They feel this was a free flow incident related to the tubing.We don¿t have lot number for the tubing but we still have the primary bag and secondary bag.(b)(6) 2020: "i do know that the primary bag was fuller after the event." "thanks for the collaboration on this incident¿.In looking at the data xxxxxxxxxx shared, i would agree¿.Vancomycin 1,000 mg/200 ml programmed at 200 ml/hr (or over 1 hr) started at 10:38 as a secondary after a patient side occlusion alarm at the start of the infusion that was restarted quickly, it ran until 11:02 at 200 ml/hr.There were a series of door opened alarms, restart and stopping between 11:04-11:05.Since i do not believe the report xxxxxxx is sharing provides a conclusive answer of why ¿ i also try to think of other potentials for an over-infusion¿.Since this is a secondary delivery ¿ i always consider the potential mechanics of an over-infusion¿.Was the secondary tubing connected properly into the upper y-site above the pump? did the primary bag look ¿fuller¿ or the secondary drip chamber dripping faster than expected ¿ based on the potential that the back check/one way valve on the primary tubing was not working and there was retrograde flow of the secondary bag into the primary fluids." it looks like 1000mg was programmed at a rate of 200ml/h with a vtbi of 200ml to infuse over a duration of 3600 seconds(3600/60seconds=60 minutes).In roughly 23 minutes, 76 mls had infused.After a series of alarms an additional 3mls infused prior to being stopped.I see a programmed dose, but not a diluent.Usually it is 250 or 500mls plus generous overfill.Whole bag of vancomycin infused.On (b)(6) 2020 in icu.

Event Description

It was reported that 36 in 15 drop secondary set w/hgr had a check valve malfunction and was too full resulting in overinfusion.The following information was provided by the initial reporter: material no: pri tubing batch no: unknown it was reported that the primary bag was found to be more full than the secondary resulting in an over infusion of vancomycin.Event description per email states: from bd rep: since the programming data does not seem to conclusively show the rationale for the vancomycin being delivered faster than intended, that is making me think beyond the programming.With xxxx stating that the primary bag looked fuller at the end, it makes me suspicious in wondering if there was a faulty back check valve on the primary tubing that lead to the retrograde flow of the secondary infusion contents into the primary bag.This one way valve should have prevented that, but if there is a bit of glue residue that prevents it from sealing completely, it can cause retrograde flow.I suspect the tubing is gone!?! if not, sending this in for testing by customer advocacy could validate this suspicion.Since this can be isolated to one tubing vs.A lot, sending in another tubing from the same lot would not necessarily help in this situation.I have spoken with our new biomed.They feel this was a free flow incident related to the tubing.We don¿t have lot number for the tubing but we still have the primary bag and secondary bag.25-sep-2020 "i do know that the primary bag was fuller after the event." "thanks for the collaboration on this incident¿.In looking at the data xxxxxxxxxx shared, i would agree vancomycin 1,000 mg/200 ml programmed at 200 ml/hr (or over 1 hr) started at 10:38 as a secondary after a patient side occlusion alarm at the start of the infusion that was restarted quickly, it ran until 11:02 at 200 ml/hr.There were a series of door opened alarms, restart and stopping between 11:04-11:05.Since i do not believe the report is sharing provides a conclusive answer of why i also try to think of other potentials for an over-infusion.Since this is a secondary delivery ¿ i always consider the potential mechanics of an over-infusion.Was the secondary tubing connected properly into the upper y-site above the pump? did the primary bag look ¿fuller¿ or the secondary drip chamber dripping faster than expected ¿ based on the potential that the back check/one way valve on the primary tubing was not working and there was retrograde flow of the secondary bag into the primary fluids." it looks like 1000mg was programmed at a rate of 200ml/h with a vtbi of 200ml to infuse over a duration of 3600 seconds(3600/60seconds=60 minutes).In roughly 23 minutes, 76 mls had infused.After a series of alarms an additional 3mls infused prior to being stopped.I see a programmed dose, but not a diluent.Usually it is 250 or 500mls plus generous overfill.Whole bag of vancomycin infused.On 9/20/20 in icu.

Manufacturer Narrative

H.6.Investigation: 1 primary tubing and 1 secondary tubing was returned by the customer.It was reported that the primary bag was found to be more full than the secondary resulting in an over infusion of vancomycin.The samples were examined for defects and abnormalities.No defects or abnormalities were observed.Functional testing was performed by using a primary bag filled with clear saline which was then used to prime the set.The secondary set was connected to a bag filled with a blue dye/water mixture, and then connected to the primary set.The sets were set up in a secondary infusion configuration with the fluid level of the secondary bag at least 9.5 inches higher than the primary bag fluid level, and all of the clamps closed.The secondary set was primed with the secondary roller clamp fully opened.Fluid flow was controlled using the primary roller clamp.After a few minutes, the blue dye/water mixture fluid from the secondary bag was found to be flowing through the check valve into the primary bag, indicating the check valve was failing to prevent backflow.The customer complaint can be verified.The issue was found to be due to a faulty check valve in the returned primary administration set.A quality notification has been sent to the supplier, and the sample has been sent for further investigation.We will continue to track this issue and watch for any emerging trends.A device history record review could not be performed on model ms3500-15 because a lot number was not provided by the customer.H3 other text : see h.10.

• Brand Name: 36 IN 15 DROP SECONDARY SET W/HGR
• 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
• MDR Report Key: 10875653
• MDR Text Key: 252834308
• Report Number: 9616066-2020-20391
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: 50885403222618
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1