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

Catalog Number H93811

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2020

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 three (3) sterile repeater pump tube sets separated from the tubing, leading to a leak.This occurred during compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction to the previously submitted g4: date received by mfr.G4: the correct baxter aware date is 12/07/2020, previously submitted as 11/10/2020.H4: the lot was manufactured between july16, 2020 - july 17,2020.H10: two actual devices were received for evaluation.Visual inspection was performed and the spike was found detached from the damaged tube set tubing of both samples.Functional testing was not performed.The reported condition was verified for both samples.The cause of the condition was not determined, however the most likely cause was due to inadequate or lack of loctite 4601 adhesive being applied during the manufacturing process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The remaining 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: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10970828
• MDR Text Key: 220689921
• Report Number: 1416980-2020-07641
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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: 60249189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1