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

Catalog Number H938724

Device Problem Fitting Problem (2183)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing of a em2400 valve set had ¿cannot be well fitted into the machine¿ (compounder).This was further described as ¿the tube (size, diameter) of the 2400 valve inlet is smaller than normal¿.The issue was identified during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured october 28, 2019 to october 29, 2019.H10: the device was received for evaluation.Unaided eye visual inspection was done which observed the silicone outlet tubing did not fit properly secure onto the exactamix compounder during setup and tubing diameter was measured out of tolerance.Functional testing was performed which revealed the outlet silicone tubing could not properly be secured on compounder during preparation.Additionally, the outer diameter of the outlet tubing was measured using a caliper and was approximately 0.288 inch at varying lengths of the tubing.The outer diameter tolerance was determined to be somewhere between 0.303 and 0.323 that verified the tubing was out of specification.The reported condition was verified.The cause of the condition could not be determined.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
• MDR Report Key: 11913841
• MDR Text Key: 253551134
• Report Number: 1416980-2021-03245
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477183
• UDI-Public: (01)00085412477183
• Combination Product (y/n): Y
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: H938724
• Device Lot Number: 60211356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1