MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX; SET, I.V. FLUID TRANSFER

Model Number H938740

Patient Problem Insufficient Information (4580)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

Tpn received from central pharmacy located on another campus for patient admitted at [redacted name].Upon initial receipt bag looked fine, but right before it was delivered up by technician, it was noted the bag was leaking.Bag was leaking tpn contents from the upper left corner through the bag seam (side where you hang from, not the port side.No tears or punctures were visible on the bag and is likely due to a defect in the bag itself.This was a 2000ml bag with lot number 04302.Assessment/recommendation: 2000 ml bags with lot number 04302 should be inspected as there is a chance they are defective and may leak their contents.Baxter opened complaint (b)(4) for this on [redacted date].Manufacturer response for 2000ml bag of total parenteral nutrition (tpn), 2000ml tpn bag, exactamix eva container (per site reporter).Site emailed with mfg rep directly.They opened complaint (b)(4) for investigating this event.

• Brand Name: EXACTAMIX
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 18621481
• MDR Text Key: 334309119
• Report Number: 18621481
• Device Sequence Number: 1
• Product Code: LHI
• 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: 01/04/2024

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: Other
• Device Model Number: H938740
• Device Catalogue Number: H938740
• Device Lot Number: 60481360
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1