MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problems Fluid/Blood Leak (1250); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The lot was manufactured from march 28, 2019 - march 29, 2019.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 discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from unspecified location.The amino acid solution was noted to be discolored.This was discovered during mixing.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was received that the statement ¿the amino acid solution was noted to be discolored¿ was erroneously added.This statement has been removed.The device was received for evaluation.Unaided visual inspection was performed which did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed which revealed a leak at the spike port cap from the spike port.The reported condition was verified.The cause of the condition was not determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 500 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9696206
• MDR Text Key: 178740681
• Report Number: 1416980-2020-00599
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938738
• Device Lot Number: 60177107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1