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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an unknown quantity of sterile repeater pump tube set disconnected.It was further reported the tubing set "popped off" causing a leak.The unspecified pump was in use at the time.It was not clarified if the event occurred during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h4 and h6.H4: the lot was manufactured from august 11, 2020 - august 12, 2020.H10: 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: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11174510
• MDR Text Key: 234097842
• Report Number: 1416980-2020-08507
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: H93811
• Device Lot Number: 60252529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PUMP; UNSPECIFIED SOLUTION