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 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a load cell module had frayed cables; further described as "cords exposed and some metal sticking out".This was identified during an unspecified process step.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed which observed the outer insulation covering of the cable was damaged/frayed exposing the ground braid and wires.No actual internal conductors exposed.Functional testing was performed which could not establish load cell communication; there was intermittent connectivity or continuity of signal wires due to the damaged frayed cord.The reported condition was verified.The cause of the condition was due to the electrical component failure.The scale cable assembly was replaced during the service refurbishment process.A service history review revealed no indication that the parts replaced caused or contributed to the reported event; the device was serviced greater than twelve (12) months.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 CORPORATION; deerfield IL
• MDR Report Key: 9527586
• MDR Text Key: 173041809
• Report Number: 1416980-2019-07201
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2400L
• Device Lot Number: 36393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1