MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 58" (147 CM) APPX 6.9 ML EXT SET W/CLAVE®, REMV 3 GANG MANIFOLD W/2 1O2® (RED, Y; STOPCOCK, I.V. SET

Model Number B5069

Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2023

Event Type  malfunction  

Event Description

The event involved a 58" (147 cm) appx 6.9 ml ext set w/clave®, remv 3 gang manifold w/2 1o2® (red, yellow), 4-way stopcock, check valve, clamp, rotating luer which was reported to have broke during patient infusion of vasporessors in the critical care department.The customer stated that during the repositioning of the patient, the manifold broke between 2 of the connections.There were three nurses involved and they stated that the manifold was not dropped and they are not aware of a reason why it would have broken or why the product would have been compromised.This issue did result in the patient having a blood pressure drop of 30+ points due to a medication no longer being administered.There was no leaking prior to the product breaking, the customer stated that the event occurred upon removal from package.There is no report of harm as a consequence of this event.

Manufacturer Narrative

A photo was provided for evaluation by the customer.The complaint of separation can be confirmed based photo shared by customer, where is observed a separation between stopcock and sub assy yellow.However, since no product samples was returned for investigation, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review could not be performed as the lot number was unknown.

• Brand Name: 58" (147 CM) APPX 6.9 ML EXT SET W/CLAVE®, REMV 3 GANG MANIFOLD W/2 1O2® (RED, Y
• 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: 17081691
• MDR Text Key: 316728259
• Report Number: 9617594-2023-00228
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B5069
• Device Catalogue Number: B5069
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• 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: UNSPECIFIED VASPORESSORS, MFR UNK