MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EUROPEAN VALVE SET, EM2400; SET, I.V. FLUID TRANSFER

Catalog Number H938724E

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em2400 valve set had a migration issue on the valve port; the lipids (white) migrated to the tubing of the monopotassium phosphate.This was observed during set up/preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured on october 31, 2022 - november 1, 2022.H10: one actual sample and a photograph was received for evaluation.A visual inspection with the unaided eye was performed on the actual sample with no issues noted.Functional testing was performed by installing the sample onto a compounder.The sample was evaluated by reproducing the customer complaint as closely as possible by attaching a lipid solution to ports 1 through 23 and sterile water to port 24 for testing.The valve set was then analyzed at various points throughout the prime, verify process, and pump calibration process and no leak was identified on any of the inlet ports.The photograph that was provided appeared to have lipid entrained into the tubing from the valve set end.Therefore, the reported condition was not verified during the actual sample evaluation, however, based on the sample photo the leak was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.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: EUROPEAN VALVE SET, EM2400
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18187773
• MDR Text Key: 328759326
• Report Number: 1416980-2023-06108
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938724E
• Device Lot Number: 60409260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1