MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938739

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was defective.The defect was further described as "the iv tubing came out of the bag" and resulted in a fluid leak.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3 and h6.Correction to g1: manufacturer's information.G1: the correct manufacturer's information is availmed c.Industrial lt.001 mz.105 no 20905 int a, col cd ind.Tijuana, baja california 22444, mexico or baxter healthcare ¿ englewood 14445 grasslands dr englewood, co.80112 united states, previously submitted as baxter healthcare corporation.H10: the device was received for evaluation.During visual inspection the spike port was received with the cover removed and the spike port membrane was not broken through to securely attach a spike membrane.The test spike easily fell out of the spike port.However, the spike was correctly.Correctly spiked membrane and sample functioned as it was intended upon proper spiking.Functional leak testing was performed, and no leak was observed.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10871220
• MDR Text Key: 217309096
• Report Number: 1416980-2020-07249
• Device Sequence Number: 1
• Product Code: LHI
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H938739
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED AMINO ACID FLUID