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

Catalog Number 08H67-01

Device Problem Leak/Splash (1354)

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

Event Date 07/20/2023

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 customer observed a 0843 rbc diluent syringe overpressure error message generated on the cell-dyn ruby analyzer.The customer cleaned the shear valve and after revitalizing, the tubing came off spraying two technicians in the face.The customer reported the liquid did not touch their eyes, nose, mouth, or nasal membranes.It was reported she did have on eye protection but not a full face mask so the solution touched their faces.The customer reported the technicians washed their faces and no other intervention was required.No impact to patient management or user safety was reported.

Event Description

The customer observed a 0843 rbc diluent syringe overpressure error message generated on the cell-dyn ruby analyzer.The customer cleaned the shear valve and after revitalizing, the tubing came off spraying two technicians in the face.The customer reported the liquid did not touch their eyes, nose, mouth, or nasal membranes.It was reported she did have on eye protection but not a full face mask so the solution touched their faces.The customer reported the technicians washed their faces and no other intervention was required.No impact to patient management or user safety was reported.

Manufacturer Narrative

The field service representative inspected the cell-dyn ruby and stated that all covers were in correctly in place when checking the instrument.The event and maintenance logs were downloaded and reviewed.The review found several instances of system initiated message (sim) (b)(6)on 20jul203 and a clean shear valve was performed four times with an auto clean performed before and after on (b)(6)2023.An occlusion was cleared with autocleaning.The customer confirmed that the shear valve was reassembled properly and that the tubing to the 20psi sensor detached.Examination of the ticket notes and in-house instruments determined that it would not be possible for an operator to get sprayed by the detachment of tubing to the 20psi sensor if the instrument doors were closed and the nose section cover assembly was installed.However, if the nose section cover assembly was installed but the doors were open, it would be possible to get splashed if the tubing to the 20psi sensor detached.A review of tracking and trending of the cell-dyn ruby did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency for the cell-dyn ruby 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: 17468908
• MDR Text Key: 320509100
• Report Number: 2919069-2023-00023
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female