MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTA-MIX EMPTY EVA BAGS 250ML, 500ML, 1000ML, 2000ML, AND 3000ML; SET, I.V. FLUID TRANSFER

Model Number H938740

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 12/13/2018

Event Type  Injury  

Event Description

Specific lots of baxter exacta-mix empty eva bags used for custom 2-in-1 and 3-in-1 parenteral nutrition compounds have been experiencing a loss of integrity when filled with solution.The affected lots at our institution do not include those already recalled under recall event 81240 on 11/2 for product code h938741.Our additional lots include multiple example with loss of integrity at seams, ports, or from spontaneous rips in bags from lot 60141892.Despite, multiple reports of these cases to the manufacturer, there has not been further guidance or follow up to our healthcare sites.Several losses of integrity have occurred while product was actively infusing to patients, leading to additional monitoring of electrolytes, additional therapy in the form of supplemental nutrition preparations and intravenous fluids, and additional resources from pharmacy to prepare replacements.We have been sequestering affected lots when an issue is discovered, but the problems have persisted with new lots obtained as replacements.

• Brand Name: EXACTA-MIX EMPTY EVA BAGS 250ML, 500ML, 1000ML, 2000ML, AND 3000ML
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL 60015
• MDR Report Key: 8174998
• MDR Text Key: 131187613
• Report Number: MW5082200
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2018
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H938740
• Device Lot Number: 60131892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention