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

Catalog Number H938724E

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 08/14/2023

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 the tubing of an em2400 valve set had a hole resulting in a leak.This was identified during priming.The tubing was changed to resolve the event.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured on september 01, 2022 - september 02, 2022.H10: the device was received for evaluation.An unaided eye visual inspection of the valve set was done which observed a tear/hole in the silicone outlet tubing at the valve body outlet port.System level testing was performed with the exactamix main module and a leak was observed at the outlet port tubing connection.The outlet tubing diameter was measured in a few spots and the results were within specification.The reported condition was verified.The cause of the condition 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.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: 17756625
• MDR Text Key: 323516677
• Report Number: 1416980-2023-04668
• Device Sequence Number: 1
• Product Code: LHI
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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: H938724E
• Device Lot Number: 60409261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/30/2023
• 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