MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM2400 LOAD CELL MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400L

Device Problem Break (1069)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that the cable of an automated compounding device (acd) was damaged with exposed wires.This event occurred during setup use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction d4: expiration date: remove ni and add na.H10: the device was received for evaluation.A visual inspection revealed unknown fluids on the unit, a scratched bag pan, and a damaged load cell/scale cable in which shield wires were exposed; the internal copper wires were not exposed.Functional system level tests were performed and the device passed the tests.The reported condition was verified.The cause of the condition could not be determined, however, a possible cause could be from attempting to move the device improperly.Cosmetic/damaged power cord defects that could not lead to user contact with electrical voltage are not likely to lead to death or serious injury.Load cell cable and display cable do not carry enough voltage to cause death or serious injury.A service history review was performed which noted the device had not been serviced within the past 12 months.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 LOAD CELL MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17391762
• MDR Text Key: 320134061
• Report Number: 1416980-2023-03771
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1