MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938741

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: the event occurred on an unspecified date in 2019.(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that three (3) 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were defective.The defect was further described as a leak coming from an unknown location.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h4 and h6.The lot was manufactured from january 27, 2018 - january 28, 2018.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 3000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10589911
• MDR Text Key: 208719067
• Report Number: 1416980-2020-05997
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477251
• UDI-Public: (01)00085412477251
• Combination Product (y/n): Y
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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 Expiration Date: 12/31/2020
• Device Catalogue Number: H938741
• Device Lot Number: 60108448
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0167-2020
• Patient Sequence Number: 1