MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3; STOPCOCK, I.V. SET

Catalog Number MC33688

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.

Event Description

The event occurred on an unspecified date and involved a 4" smallbore quadfuse ext set w/4 microclave® clear, 3 check valves, 4 clamps (3 white, red), rotating luer.It was reported that the patient had post op hypotension throughout the night.Epinephrine was restarted (using existing set up from or) overnight however pressures were not super responsive to epinephrine.Later required 15cc/kg of albumin and packed red blood cells.Pressures responded to volume.Unclear if the lack of response to epi was due to the severe leaking or not.The patient was not harmed as a result of the reported issue.

Manufacturer Narrative

The complaint of leaks can be confirmed based on the drop of leaks observed in the photo provided by the customer.However, since no product sample was received for investigation a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.

• Brand Name: 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 3 CHECK VALVES, 4 CLAMPS (3
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19008949
• MDR Text Key: 339331209
• Report Number: 9617594-2024-00352
• Device Sequence Number: 1
• Product Code: FMG
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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 Catalogue Number: MC33688
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: ALBUMIN, MFR UNK; EPINEPHRINE, MFR UNK; PACKED RED BLOOD CELL, MFR UNK