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

Catalog Number 2400L

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em 2400 load cell module had a load cell cord frayed with exposed wires.This was noted in the pharmacy department.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was returned to the depot and the evaluation is complete.A visual inspection was performed and noted the outer cable insulation was frayed, exposing the ground braid.The reported problem was verified.The cause of the condition could not be determined.A device history review was performed and found no indications of nonconformance during the manufacture of this product.To correct the condition, the cable was replaced.The device was serviced to meet functional specification.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, LOAD CELL MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• 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: 7772202
• MDR Text Key: 116779738
• Report Number: 1416980-2018-05009
• 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: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• 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: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• 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: Reuse
• Patient Sequence Number: 1