MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REPLACEMENT, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400MR

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address - (b)(6).The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a power cord sheath is cut and wires were exposed during setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: d1 brand name, d4 information, g1 information (update to include 2 potential manufacturers), g2 (add source), h8, h10.G1 manufacturing facility - the device was manufactured at one of the two following manufacturing sites: baxter healthcare - englewood 14445 grasslands dr englewood, co 80112 united states.Plexus corporation 2500 millbrook drive buffalo grove, il 60089 united states.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REPLACEMENT, MAIN MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; see h10; see h10; see h10 CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13673845
• MDR Text Key: 286640037
• Report Number: 1416980-2022-00894
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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 Catalogue Number: 2400MR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/20/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1