MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number 08H67-01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The technical service specialist while onsite noticed the blackened charred socket from the power distribution board on the cell-dyn ruby analyzer.The attached picture supports the evidence of the charred socket on the power distribution board.There were no patients involved and no impact to patient management or user safety reported.

Manufacturer Narrative

The investigation included review of product historical data, product labeling and consultation with field service engineer.Review of product historical data for any trends and all customer complaints received for this issue did not identify any trends or abnormal complaint activity.Review of device history records for the cell-dyn ruby found that this hazard of burns, fire, smoke resulting from system components, i.E., power supply is addressed.A control listed is the use of covers, and a control verification listed is that system is built to safety standards such as iec 61010-1, ul 61010a-1.The overheated area at the pdm was contained.In addition, the pdm is located inside the chassis of the cell-dyn ruby analyzer and cannot be accessed by the customer.However, there is not enough information to conclusively attribute what caused the burning at the pdm.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the power distribution pcb assy, cdruby, part number 8960310001.

• Brand Name: CELL-DYN RUBY SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10788500
• MDR Text Key: 214718560
• Report Number: 2919069-2020-00035
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1