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

Model Number 08H67-01

Device Problem Leak/Splash (1354)

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

Event Date 12/07/2022

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 reported accidently getting cell dyne enzymatic cleaner in the eye during maintenance.The instrument was not running at the time.The customer flushed eyes thoroughly.The customer was not wearing glasses/protective eye equipment.The customer went to emergency room and her eyes were flushed again.No further treatment.No additional impact to the user was reported.No impact to patient management was reported.

Manufacturer Narrative

The customer reported spraying of the enzymatic solution into her eyes while performing maintenance on the cell-dyn ruby.The cell-dyn ruby instrument was in stopped mode when the issue occurred.Use error contributed to the event as no eyeglasses or gloves were worn for protection.A review of tracking and trending of the cd enzym clnr and the instrument did not identify any trends for cell-dyn ruby instrument, or the cd enzym clnr with regards to the current issue.The device history records were reviewed, and no non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the cell-dyn ruby for serial number (b)(6) or the cd enzym clnr 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: 15979499
• MDR Text Key: 308565385
• Report Number: 2919069-2022-00036
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CELL DYN ENZYMATIC CLEA, 0H996-4R, UNKNOWN; CELL DYN ENZYMATIC CLEA, 0H996-4R, UNKNOWN
• Patient Sex: Female