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 Crack (1135); 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 description 4-way high flow stopcock w/rotating luer.The customer complained that device was cracked and leaking during use on a patient in the intensive care unit department.On december 12-dec-2022, the customer emailed gcm with the following updated information: the device leaked from the cracked site of the stopcock during infusion of norepinephrine, propofol and normal saline.Medication was leaking and it was not infusing into the patient.As a result, the patient presented low blood pressure and was under-sedated.A small blood loss (less than 100ml) and bleed back was also reported during the event.Minor harm was reported and resolved.It was unknown how long into the infusion that the crack and leakage occurred.

Manufacturer Narrative

The device is not available for investigation.Without the return of the 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: 16004970
• MDR Text Key: 308538116
• Report Number: 9617594-2022-00328
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/19/2022
• 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: NOREPINEPHRINE, MFR UNK.; NORMAL SALINE, MFR UNK.; PROPOFOL, MFR UNK.