MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM 2400, MAIN MODULE; SET, I.V. FLUID TRANSFER

Catalog Number H938724

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

It was reported a valve was missing on an em2400 valve set.The event occurred during compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Smetzer, judy; cohen, michael; bertagnoli, shannon; shastay, ann; and shultz, kelly.¿more on leaking ports with exactamix 2400 compounder.¿ acute care ismp medication safety alert, vol.27, no.19, 2022, pp 4-5.The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photograph, the valve set was not inside its packaging.The reported condition was verified.Due to the provided sample, no further testing could be performed.Therefore the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN MODULE
• 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: 15962037
• MDR Text Key: 307938559
• Report Number: 1416980-2022-06806
• Device Sequence Number: 1
• Product Code: LHI
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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: H938724
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/26/2023
• 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