MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that four (4) eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking at the corner.The leaks were discovered during setup/preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : device manufactured between: 05/15/2018 to 05/17/2018.Four devices were received for evaluation.A visual inspection with the unaided and with magnification revealed a tear at the lower right corner edge on sample 1.Upon functional testing with tap water a leak was observed.The reported condition was verified.The cause of condition could not be determined.Functional testing of samples 2, 3, and 4 revealed leaks at the spike port caps and no leaks were observed in the corner of the bags.Functional testing was performed by filling the bags with tap water.The cause of the leaks could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2000 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: 8203964
• MDR Text Key: 131701141
• Report Number: 1416980-2018-08068
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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: 04/30/2021
• Device Catalogue Number: H938740
• Device Lot Number: 60126015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/20/2019
• 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