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

Catalog Number H93811

Event Type  malfunction  

Manufacturer Narrative

The events occurred over the last "few months" from the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the unspecified quantity of sterile repeater pump tube sets were leaking during use.The leaks were observed from either the rubber piece (that goes through the pump) that connects to the blue plastic piece or from a slit in the rubber piece or from the tubing that connects to the spike being large resulting in the spike falling out (not further specified).There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured between may 29, 2019 to may 30, 2019.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 10073126
• MDR Text Key: 191536667
• Report Number: 1416980-2020-02813
• 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
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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: 04/30/2022
• Device Catalogue Number: H93811
• Device Lot Number: 60187270
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1