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

Model Number 08H67-01

Device Problems Thermal Decomposition of Device (1071); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

The customer was performing preventative maintenance and detected a burned board.The instrument was stopped.No injury to the user was reported.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.Section e1 facility name complete entry(b)(6).

Event Description

The customer was performing preventative maintenance and detected a burned board.The instrument was stopped.No injury to the user was reported.No impact to patient management was reported.Additional information provided by the customer on (b)(6) 2023.The customer reported the board was damaged and not burnt.

Manufacturer Narrative

Additional information in section b5 - describe event or problem and d10 - concomitant product.During preventive maintenance on the cell-dyn ruby, it was thought a burned board was found.However, upon further examination by field service representative (fsr) it was determined that the vpm board (pcb assy, vpm, ruby rohs,) was damaged, not burnt.Field service replaced the vpm board and 2 valves to resolve the issue.Return testing was not completed as returns were not available.An instrument service history review revealed there were no service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending of the cell-dyn ruby did not identify any trends associated with the complaint issue.A review of tracking and trending for the pcb assy, vpm, ruby rohs, did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the cell-dyn ruby for serial (b)(6), or the pcb assy, vpm, ruby rohs, was identified.Corrected information in h6 - adverse event problem: medical device problem code changed from a1006 to a04.

• 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
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16700821
• MDR Text Key: 312881840
• Report Number: 2919069-2023-00009
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PCB ASSY, VPM, RUBY ROHS, (B)(6), UNKNOWN.