MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VENTED HIGH VOL. INLET, N/S; SET, I.V. FLUID TRANSFER

Catalog Number H938174

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: the reporter stated that the issues occurred on unspecified dates over the past two weeks.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that while connecting an unspecified quantity of vented high-volume inlets to valve sets, there were connection issues.This was further described as, the connections were loose which caused a complete disconnection and resulted in leaks.This was identified prior to patient use.There was no patient involvement.No additional information was added.

Manufacturer Narrative

B5: upon due diligence, it was reported there were two (2) bags that leaked.H10: the actual device was not available; however, two (2) companion samples were received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was completed, and the device performed according to product specifications.The reported condition was not verified.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: VENTED HIGH VOL. INLET, N/S
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10339383
• MDR Text Key: 200851554
• Report Number: 1416980-2020-04495
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475790
• UDI-Public: (01)00085412475790
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/21/2022
• Device Catalogue Number: H938174
• Device Lot Number: 802810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1