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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

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 abbott field representative (fsr) determined damaged shm1 board and related solenoid during the service on cell-dyn ruby analyzer.The fsr was on-site for service due to analyzer failure.The field service representative (fsr) noticed burnt shm1 board and related solenoid.There was no visible smoke or spark detected.There was no impact to user safety or patient management reported.There was no involvement of patient.

Manufacturer Narrative

During the requested site visit, the field service engineer (fse) performed troubleshooting procedures, and found that the pcb assy, shm, rohs, list number 8960229301, lot number 9602293-a, was burnt due to leakage from a damaged peristaltic pump tubing.A review of all complaints associated with pcb assy, shm, rohs, list number 8960229301, lot number 9602293-a, and a review for complaint trends for the list number was performed.The review did not identify any adverse trends and the complaint activity was normal for the list and lot numbers.A review of the product historical data did not find a product issue related to the complaint incident.Labeling was reviewed and found to be adequate for the complaint issue.Based on the available information no product deficiency of the pcb assy, shm, rohs or cell dyn ruby analyzer, serial number (b)(6), was identified.

• 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: 16471616
• MDR Text Key: 310548869
• Report Number: 2919069-2023-00006
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1