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 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Visual inspection was performed and a frayed cable was identified.The internal wires however were not exposed.The reported condition was confirmed.The cause of the condition was likely due to the customer lifting main module and\or load cell after operation and forgetting to disconnect putting strain on the cable causing it to pinch and eventually break\tear the outer shield.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the cord (load cell module) of an exacta mix automated compounding device was damaged.It was further reported that the jacket on the cord was torn and the wires were exposed.This issue was noted during programming/setup.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): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 11196641
• MDR Text Key: 245731066
• Report Number: 1416980-2020-08551
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2021

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: 2400L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/19/2021
• 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