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

Catalog Number H93811

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the connector of a repeater pump tube set broke during mixing.This was identified during set up and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured from may 14, 2019 - may 16, 2019.The device was received for evaluation.Unaided visual inspection was performed and it was observed the finger grip connector was damaged at the tip.Magnification identified the finger grip connector damaged (broken off) and thread area of the connector damaged.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: TUBE SET, STD VOL, STER
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10135693
• MDR Text Key: 194603464
• Report Number: 1416980-2020-03251
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

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: 12/31/2021
• Device Catalogue Number: H93811
• Device Lot Number: 60168634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1