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

Catalog Number H938739

Device Problems Fluid/Blood Leak (1250); Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The issue occurred on an unknown date "a few weeks ago".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 the three (3) fill ports of a 1000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag were not attached as normal which caused the solution to leak on the outside of the bag.This was further described as the three (3) fill ports were not attached as normal on the inside of the bag (inside of the seams) but instead were attached on the outside of the bag.This was noted during bag preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : device manufactured between november 10, 2018 to november 11, 2018.The device was received for evaluation.A visual inspection was performed and it was noted that the top port tubing was detached from the inside of the bag and protruding outside the back of the bag of all 3 ports.Functional testing was also performed and it was noted that the top of the fill port was leaking outside the back of the bag when attempting to fill the bag.The reported condition was verified.The cause of the reported condition was undetermined.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: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8793552
• MDR Text Key: 151133290
• Report Number: 1416980-2019-03791
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477237
• UDI-Public: (01)00085412477237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: H938739
• Device Lot Number: 60158759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1