MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Model Number B4018

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

The event involved a 4-way high flow stopcock w/rotating luer where the customer reported on three occasions, blood was backing up on proximal central venous catheter line at the junction of the stopcocks.The patient was on propofol and levophed where both drugs were found dripping on the floor.The patient woke up and their blood pressure decreased as a result of the leak.All three times the stopcocks and tubing were changed out.There was no cracks on stopcocks and no loose connections noted.There was patient involvement and no human harm.This is the first of three occurrences.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.Without the returned device, a probable cause is unable to be determined.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• 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. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16286141
• MDR Text Key: 308860807
• Report Number: 9617594-2023-00052
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B4018
• Device Catalogue Number: B4018
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LEVOPHED, MFR UNK; PROPOFOL, MFR UNK; UNSPECIFIED CVC (CENTRAL VENOUS CATHETER), MFR UNK