MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 206680490

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

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

The event involved a ext set 17in macro 0.2 m-fltr clv-y sl where the secure lock dislodged at a connection point.Blood backed up into the tubing and an unspecified drug leaked onto the floor.There was a delay in discharge as tubing was changed.The patient and floor were cleaned.The filter came apart at the connection point where the tubing connects to the filter.It was a clean break at the tubing.The connection side of the filter with the slide clamp.There was patient involvement and unknown adverse event or human harm.

Manufacturer Narrative

The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

• Brand Name: EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL
• 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: 18493952
• MDR Text Key: 333136212
• Report Number: 9615050-2024-00028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)250101(10)5719984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151969
• 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: 01/11/2024

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: 206680490
• Device Lot Number: 5719984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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 DRUG, MFR UNK