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

Catalog Number H938724

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

It was reported that valve 20 of an em2400 valve set was cracked and was drawing air.This was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

D4: lot #: suspect lots 60439522 and 60438225 were reported.E1: initial reporter address: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the suspected lot # 60439522 was manufactured from february 24, 2023, to february 28, 2023.H4: the suspected lot # 60438225 was manufactured from february 20, 2023, to february 23, 2023.H10: the actual device was received for evaluation.Visual inspection was performed and valve set port 20 was observed with valve core damaged and was incorrectly oriented.Functional testing and duplication of the issue could not be performed due to the damage and incorrect orientation.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted for the suspected lot numbers 60439522 and 60438225, and there were no deviations found related to this reported condition during the manufacture of these lots.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: 17492447
• MDR Text Key: 321235838
• Report Number: 1416980-2023-03989
• Device Sequence Number: 1
• Product Code: LHI
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938724
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• 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: Initial
• Patient Sequence Number: 1