MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SET, I.V. FLUID TRANSFER

Catalog Number H93811

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during an unspecified date (b)(6) of 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a sterile repeater pump tube set had a tear in the tubing.This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured from september 03, 2018 -september 05, 2018.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A zoomed in area on the photograph observed a small droplet at the poly-vinyl chloride (pvc) tubing where it was attached to the connector (dark blue) of the pump head assembly.Due to the nature of the sample (blurred photo), the reported condition of tear in the tubing could not be verified; however, a small droplet was identified indicative of the reported condition.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: TUBE SET, STD VOL, STER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10043857
• MDR Text Key: 190527399
• Report Number: 1416980-2020-02636
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• 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: 06/10/2020

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 Expiration Date: 08/31/2021
• Device Catalogue Number: H93811
• Device Lot Number: 60147043
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1