MAUDE Adverse Event Report: ICU MEDICAL INC 4IN SMALLBORE EXT SET WITH 1.2 MICRON FILTER; STOPCOCK, I.V. SET

Catalog Number B1755

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2020

Event Type  malfunction  

Event Description

Intralipids infusing using 1.2 micron filter extension.Iv pump kept alarming occlusion, filter extension changed and lipids infused without alarm.Happened with 3 different patients, 2 saved packaged and have different lot numbers.

• Brand Name: 4IN SMALLBORE EXT SET WITH 1.2 MICRON FILTER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 9798145
• MDR Text Key: 182332526
• Report Number: 9798145
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: B1755
• Device Lot Number: 3961763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1