MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H93811

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the spikes of two (2) sterile repeater pump tube sets separated from the tubing.This was identified while pumping sterile water prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4 and h6.H4: the lot was manufactured from july 19, 2020 - july 21, 2020.H10: two (2) actual samples were received for evaluation.During visual inspection, the spike of the first sample was observed attached to the tubing; however, the vent filter was missing.Functional testing was performed on the first sample via a repeater pump system level testing by using sterile water and a leak was observed at the area of the spike where the vent filter was received missing.The reported condition was verified.The cause of the condition could not be determined.During visual inspection, the second sample had detached spike which was not received with the sample.Due to the nature of the second sample, functional testing could not be performed.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to an inadequate or lack of loctite adhesive being applied in the manufacturing process at the spike connection to the tubing.However, this could not be determined due to the condition of the received sample.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: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11272353
• MDR Text Key: 230068588
• Report Number: 1416980-2021-00359
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

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: 06/30/2023
• Device Catalogue Number: H93811
• Device Lot Number: 60249192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1