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

Device Problem Material Separation (1562)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device, probable cause is unable to be determined.

Event 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
• Type of Device: 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
• MDR Text Key: 300645291
• Report Number: 9617594-2022-00281
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709080799
• UDI-Public: (01)00887709080799(17)250601(10)4878904
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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
• Treatment: CARRIER FLUID, UKN MFR; FEMORAL CENTRAL ACCESS, UKN MFR; MIDAZOLAM, UKN MFR; NOREPINEPHRINE, UKN MFR
• Patient Outcome(s): Required Intervention