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

Catalog Number H938724

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the em2400 valve set leaked where the tubing connected to the hard plastic of the valve body.It was further reported that when attempting to redo the whole setup, the tubing "split at the joint".This was identified during setup prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added d10, h3, h4 and h6.H4: device manufactured between march 06, 2018 to march 07, 2018.H10: one (1) actual and one (1) companion devices were received for evaluation.A visual inspection was done and observed the actual sample was received with damaged tubing and companion sample with misaligned tubing.No functional testing was performed for this complaint.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: 10402640
• MDR Text Key: 202754389
• Report Number: 1416980-2020-04942
• 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
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: H938724
• Device Lot Number: 60116213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1