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

Catalog Number H938724

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unspecified date of (b)(6) 2022, further described as "two weeks ago".Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em2400 valve set leaked after the device was set-up.One of the valves had a missing piece (valve core).There was no patient involvement.No additional information is available.

Manufacturer Narrative

The event occurred on an unspecified date of (b)(6) 2022, further described as "two weeks ago".Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em2400 valve set leaked after the device was set-up.One of the valves had a missing piece (valve core).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 november 26, 2020 ¿ november 30, 2020.Correction to f10/h6: health effect ¿ impact codes: from f26 to f27.H10: the device was received for evaluation.Visual inspection was performed which observed that the valve core of port 2 was missing.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to assembly issue during the manufacturing process.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: 13536925
• MDR Text Key: 285645240
• Report Number: 1416980-2022-00530
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477183
• UDI-Public: (01)00085412477183
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002705
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: H938724
• Device Lot Number: 60269662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• 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
• Treatment: NI.