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 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Visual inspection was performed, and the scale cable wires were observed to be exposed.The braided ground shielding was exposed but no copper conductive wires were exposed.System testing was performed with no issues.During ctf testing, the device alarmed ¿unable to communicate with the device under test" due to the exposed cable.The reported condition was verified.The cause was due to a damaged outer sheath on the scale cable assembly.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the cable (load cell module) of an exacta mix automated compounding device was damaged.It was further reported that the load cell cable were exposed.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: 11037175
• MDR Text Key: 222360719
• Report Number: 1416980-2020-07899
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/18/2020

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: Health Professional
• Device Catalogue Number: 2400L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/18/2020
• 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: Initial
• Patient Sequence Number: 1