MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number NOT PROVIDED

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/09/2024

Event Type  malfunction  

Event Description

The event involved an unknown tubing set where it was reported that the patient's aline reading went flat on monitor.Upon entering the room blood was gushing from left radial arterial line (aline).Further investigation proved that the aline tubing had broke in two pieces close to the tab where you draw blood.Immediate actions made wherein stop cock turned toward the patient to stop the bleeding.Morning labs drawn, labs sent and then patient bathed.There was patient involvement and unknown patient harm.The event occured in the cardiovascular intensive care unit (cvicu).

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.

• Brand Name: UNSPECIFIED TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19094197
• MDR Text Key: 340685108
• Report Number: 9615050-2024-00302
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 04/11/2024

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: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/11/2024
• 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