MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Model Number	AM3090
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, probable cause is unable to be determined.
Event or Problem Description
It was reported that, on an unknown date, a 10" ext set w/3-port nanoclave® manifold, check valve, clamp, luer lock broke off the left femoral central access when the registered nurse (rn) attempted to disconnect a midazolam infusion in order to change the syringe/tubing.This caused back up of blood from the patient into the multi connector.The patient had norepinephrine infusing at the time and subsequently had a drop in blood pressure (map 50 mmhg).The rn administered a bolus of norepinephrine.The initial reporter entered the room and assisted with transferring a norepinephrine infusion directly to the access port as an increase in infusion was required.A new multi-connector was primed and attached for all infusions.The carrier fluid required to be increased temporarily to facilitate the infusion of vasoactive meds.Once the patient¿s blood pressure (bp) stabilized, the rn was able to return norepinephrine and carrier fluids to previous rates.No additional information is available at this time.

• Brand Name: 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa.
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15490164
• Report Number: 9617594-2022-00281
• Device Sequence Number: 16615700
• Product Code: FMG
• UDI-Device Identifier: 00887709080799
• UDI-Public: (01)00887709080799(17)250601(10)4878904
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: AM3090
• Device Catalogue Number: AM3090
• Device Lot Number: 4878904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARRIER FLUID, UKN MFR; FEMORAL CENTRAL ACCESS, UKN MFR; MIDAZOLAM, UKN MFR; NOREPINEPHRINE, UKN MFR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown