MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX 2000ML EVA CONTAINERS - EMPTY; SET, I.V. FLUID TRANSFER

Lot Number 60231190

Device Problem Leak/Splash (1354)

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

Event Date 08/27/2020

Event Type  malfunction  

Event Description

During our inpatient pharmacy's preparation of daily parenteral nutrition supply - two 2-liter bags of solution that had just been pumped were found to be leaking from the middle port of the bags.(this was noted to be occurring from the "center" port, normally used by rns when attaching infusion lines to the bag, which still had the clear plastic tabs attached, and had not yet been manipulated during our production process.) product information: exactamix 2000ml eva containers, ref # h938740, (lot # is 60231190) baxter healthcare (b)(4) - an affiliate of baxter healthcare corp, usa - product of (b)(4).An addition (b)(4) bags of the same lot were identified and removed from our stock supply for now.

• Brand Name: EXACTAMIX 2000ML EVA CONTAINERS - EMPTY
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 10477251
• MDR Text Key: 205333779
• Report Number: MW5096354
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 60231190
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1