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

Catalog Number H938724E

Device Problems Fitting Problem (2183); Air/Gas in Device (4062)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

It was reported that three (3) em2400 valve sets were defective and would draw air into the connecting bag.This was discovered during compounding.The sets did not seem to fit exactly; therefore, air was drawn.New sets from a different batch were used to continue compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H4: device manufacture date: the lot was manufactured from september 1, 2022, to september 2, 2022.H10: the actual devices were not available; however, ten (10) companion samples were received for evaluation.A visual inspection with the unaided eye was performed on cavity b for all ten samples and it did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed on two (2) randomly selected samples and the reported issue was not observed.Functional testing was performed with the two selected samples on by installing each valve set sample onto a compounder and a leak or air was not observed during the testing.Additionally, no leak was verified when attempting a ¿ui¿ flush after prime and during the pump calibration process.The reported condition was not verified on the companion samples.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: 17054589
• MDR Text Key: 316448238
• Report Number: 1416980-2023-02696
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938724E
• Device Lot Number: 60392778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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