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

Catalog Number H938724

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em2400 valve set was leaking.The reporter stated that the set did not connect tightly to the valve manifold of the main module.This was observed during setup/preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, three (3) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed with no issues were noted.The reported condition was not verified.This issue is being further investigated.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 ; 2242702068
• MDR Report Key: 14893834
• MDR Text Key: 296055354
• Report Number: 1416980-2022-03448
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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 Expiration Date: 05/31/2024
• Device Catalogue Number: H938724
• Device Lot Number: 60321738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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