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

Catalog Number H938724

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the outlet tubing connector of an unspecified quantity of em2400 valve sets failed (were broken) and leaked.The issue was identified during pumping of formula bags in the pharmacy.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Device manufacture date: the lot was manufactured from april 20, 2023 to april 21, 2023.The actual device was not available; however, 24 unopened companion samples were received for evaluation.A visual inspection with the unaided eye did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed on randomly selected samples of each cavity and the reported issue was not observed.Functional testing was performed with a random sample from cavity a and cavity b by installing each valve set sample on the compounder and no issue of a leak was observed during testing.Both samples were 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 and verify process and pump calibration process.The reported condition was not verified.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: 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: 17979795
• MDR Text Key: 326198121
• Report Number: 1416980-2023-05379
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477183
• UDI-Public: (01)00085412477183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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 Catalogue Number: H938724
• Device Lot Number: 60454471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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