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

Catalog Number	2400-L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.During visual inspection the cable outer insulation has been torn open a couple of inches from the strain relief of the unit housing, exposing the ground braid, no wires or internal conductors exposed.System functional test was performed, and no errors or issues were observed despite the frayed cable.The reported condition was verified.The cause of the condition could not be determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was serviced to meet functional specification.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the em 2400, load cell module had frayed cord and metal showing inside.There was no patient involvement.No additional information is available.

• Brand Name: EM 2400, LOAD CELL MODULE
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• MDR Report Key: 8928887
• Report Number: 1416980-2019-04619
• Device Sequence Number: 233643
• Product Code: NEP
• UDI-Device Identifier: 00085412482613
• UDI-Public: (01)00085412482613
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2019

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
• Operator of Device: Other
• Device Catalogue Number: 2400-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1