MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET

Model Number	B1729
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
There has been three separate events in the nicu involving the use of the icu medical b1729 luer lock extension set with 0.2 micron filter.The first event ((b)(4)) noted the malfunctioning of a b1729 iv ext set connected to an umbilical venous catheter (uvc).When the micron filter was placed at the same level as the newborn patient, the uvc bled back into the iv line and tubing.The micron filter worked as expected when held in the "house up" position.The iv flow rate during this event was 17.5 ml/hr.The issue with the b1729 ext set started when the filter had to be added to the no-port iv tubing.The 0.2 filter is shorter than the filters used in the past which are 14 cm in total length.The second event ((b)(4)) involved blood backing up in the uvc line using the b1729 micron filter connected to a bd alaris iv infusion set.The bd iv pump was used to infuse fluids at a rate of 7.3 during a total parenteral nutrition (tpn) procedure.Rn noted the presence of blood in the line and called the physician.Health care providers noted that fluid started to flow normally on the iv set when the filter was held in a vertical position (up higher in the air).Blood started backing up in the line immediately after the filter was lowered back down despite using a 7.3 pump rate.A large amount of backed up air was noted on the filter as well.The filter is being used a substitute product to a shortage of the regular product due to covid-19.The third event ((b)(4)) involved the use of a dual lumen uvc, large volume bag and a syringe pump infusing fluids into a patient.The issue started with the infusion of gentamicin.All pumps began alarming occlusion and neither the outgoing nurse nor the neonatal nurse practitioner were able to flush line/lumen.It is unclear if the infusion into the lumen was from the large volume bag or syringe pump.Physician was called to assess line.Physician was able to get line to flush sluggishly.Physician ordered fluids to be infused by syringe pump only, and to loosen sutures on uvc for being too tight.Fluids were able to infused into uvc without incident afterwards.

• Brand Name: ICU MEDICAL
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 10312078
• Report Number: 10312078
• Device Sequence Number: 10969094
• Product Code: FMG
• UDI-Device Identifier: 00887709073951
• UDI-Public: (01)00887709073951
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2020
• Report Date (Section F): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: B1729
• Device Catalogue Number: B1729
• Device Lot Number: 4734904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 4 DA
• Date Report Sent to FDA: 07/17/2020