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

Catalog Number H938739

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing facility - this device was manufactured at one of the two following manufacturing sites: (b)(4).The device has been received and the evaluation is in progress.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 leaked.It was further reported the leak was due to the spike of a clearlink system non dehp solution set slipping out half way from the infusion port of the bag.This was identified during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device evaluation was completed.Unaided eye visual inspection was performed which identified the spike port with the cover removed.The membrane was not sufficiently broken for a secure spike to occur.Functional testing was performed with tap water which revealed droplets from the spike port that was received partially broken.The membrane was spiked properly using a test spike and the spike was securely connected to the spike port.The reported condition was verified; however the bag was able to connect successfully to a test spike.The cause of the condition could not be determined; however, the most probable cause is user related.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: 11349311
• MDR Text Key: 232589673
• Report Number: 1416980-2021-00748
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938739
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLEARLINK SYSTEM NON DEHP SOLUTION SET; CLEARLINK SYSTEM NON DEHP SOLUTION SET