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

Catalog Number 2400L

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a load cell module's cable was frayed and the wire exposed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

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.Visual inspection revealed that the insulation around the cable wires was loose at the connector end.Functional testing was performed and passed with no issues noted.The cable was found to be fully functional; however, cosmetic damage to the cable was verified.The cause of the condition was not determined.The cable was replaced to resolve the issue.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: 6504442
• MDR Text Key: 73233703
• Report Number: 1416980-2017-03427
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

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: 04/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• 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