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

Catalog Number H938724E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: thorncliffe park brookdale road should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a em2400 valve set leaked.During compounding, port 19 (ascorbic acid) was pulling into port 22 (cernevit).There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4, h6 and h10.H4: the lot was manufactured from july 18, 2022 to july 19, 2022.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed and the reported issue was not observed.The valve set was analyzed at various points throughout the prime and verify process and pump calibration process.A leak was not verified on all inlet ports during ui flush after prime and pump calibration delivery 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: 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: 16431011
• MDR Text Key: 310339265
• Report Number: 1416980-2023-00645
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H938724E
• Device Lot Number: 60381983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• 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