MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Model Number	08H00-03
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer was observing multiple issues with the celldyn sapphire with liquid leaking out of tubing behind the valve of the analyzer.The customer was working with a field service engineer (fse) over the phone near the leak and it sprayed out of the tubing.The customer felt a drop on his forehead.The customer was not wearing goggles or a face shield.There was no injury/intervention to the customer reported.
Additional Manufacturer Narrative
Use error may have contributed to the complaint issue regarding the use of personal protective equipment (ppe) while using the product.No protective eyewear as per product labeling was in use at the time of the incident.No trends or similar issues for splashing/exposure as described in this ticket were identified.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the biological and chemical safety hazards that may exist.Based on the investigation no product deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 10170382
• Report Number: 2919069-2020-00025
• Device Sequence Number: 2116246
• Product Code: GKZ
• UDI-Device Identifier: 00380740016623
• UDI-Public: 00380740016623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08H00-03
• Device Catalogue Number: 08H00-03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1