MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EM 2400, LOAD CELL MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400L

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the event.A visual inspection was performed, and it was noted the cable¿s outer insulation had been punctured or torn open, exposing the ground braid.No internal wires or conductors were exposed.The reported condition was verified.The cause of the reported condition could not be determined; however, it is likely due to improper routing of cable under the main module, and or normal wear and tear of use by customer.The scale cable assembly was to be replaced during the service refurbishment process to correct the reported issue of exposed wires.The device was serviced to meet functional specification.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the load cell module cable of an automated compounding device (acd) hardware had exposed wires.The exposed wires were identified during power up of the acd hardware during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: EM 2400, LOAD CELL MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10765580
• MDR Text Key: 214177240
• Report Number: 1416980-2020-06770
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 10/08/2020
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1