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

Catalog Number H938724E

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that tubing of an em2400 valve set "came out of its housing" and detached from the valve port.This occurred during purging (priming).There was no difficulty when the tubing was installed in the pump rotor.A new set was used to continue with the set up.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H4: device manufactured on october 05, 2022 to october 06, 2022.H10: the device was received for evaluation.A visual inspection was done which observed the valve set silicone outlet tubing was received detached from the valve body outlet port.As a result, functional testing could not be performed.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: 18210252
• MDR Text Key: 329026587
• Report Number: 1416980-2023-06154
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

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: 60401533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 12/29/2023
• 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