MAUDE Adverse Event Report: IMS033G FLOW REGULATOR IV SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number IMS033G

Device Problems Inaccurate Flow Rate (1249); Mechanical Problem (1384); Insufficient Flow or Under Infusion (2182); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  Injury  

Event Description

Product / device: i medical / integrated medical systems inc."ims033g iv administration set" (with gvs easydrop® flow regulator).Package information: ims033g flow regulator set.Lot: 10361120.Lbl-003 revb.2023-11-14 i have a double lumen picc line that i infuse dextrose 5% sodium chloride 0.9% with kcl 5meq 1000 ml through daily since (b)(6) 2020.On (b)(6) 2021, the needless connector for my infusion malfunctioned.I didn't realize at first that it was the connector that had malfunctioned, only that i was unable to infuse at the prescribed rate of 250 ml / hr.The malfunctioning rate was less than 100 ml / hr.The next day, my home healthcare iv nurse confirmed i had been using the devices as instructed and correctly.The iv nurse changed the claves on my picc, she said both sides had good blood return and while one was a stiffer flush, flushed ok.The other flushed great.Despite all this, that day (b)(6) 2021, i could not get the fluids to infuse at a rate higher than around 90 ml / hr.I decided to test the infusion set and clave over the sink to see how it was running.What i found was a tendency to connect poorly and run at a rate on the 3 infusion sets i opened and tried, it seemed that the luer lock end on the infusion tubing was unable to reliably, fully engage the valve on a clave, which - i believe - is what resulted in insufficient flow during infusion.The luer lock type on the "i medical" "ims033g iv administration set" is a male "swivel" lock, and it seems like there may be a problem with the molding.It's not visibly or palpably misshapen, but it does not fit well into the claves, stopping short of fully engaging the valve to open it for fluid.I have pictures, but as it's a dynamic issue, you really need to see it in video or in person.I do have video, if it's wanted and someone can let me know where to send it, i will.I am attaching pictures of one of the infusion set packages.It's 3 photos of one package, i wanted the print large enough to read and to get the whole package info.I alerted my iv supply company, (b)(6) but they did not want the equipment information from me, or the equipment itself (which i've saved) to test the quality.My iv nurse has said another of her patients is also having a similar problem with their infusion set.I don't know if theirs is the same as mine.I have no other details than this on this other incident of slow and unreliable infusion.I have a work-around now, including a pump that has a different connector for the infusion line.However, i am concerned that the i medical / integrated medical systems' infusion set i was using may have a defect that can unpredictably interrupt, slow, or otherwise change the infusion of medication for patients.Sorry, i'm not up for a full inventory.The iv supplier should be making this report, not me.I'm tired.So this is all you're getting right now.Fda safety report id # (b)(4).

• Brand Name: IMS033G FLOW REGULATOR IV SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11930049
• MDR Text Key: 254487781
• Report Number: MW5101693
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/28/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/14/2023
• Device Model Number: IMS033G
• Device Lot Number: 10361120
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 48