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

Model Number	08H00-01
Medical Device Problem Codes	Overheating of Device (1437); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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 observed error code 1050, aspiration probe failed to return to upper position, on the cell-dyn sapphire analyzer.While troubleshooting the issue, upon plugging in the aspiration assembly, a spark was observed and a burning odor was present.Further investigation indicated the printed circuit board (pcb) had visible burn marks.A replacement pcb was ordered.The charring was isolated to the pcb.No fire was observed and no injury occurred.Null.
Event or Problem Description
The customer observed error code 1050, aspiration probe failed to return to upper position, on the cell-dyn sapphire analyzer.While troubleshooting the issue, upon plugging in the aspiration assembly, a spark was observed and a burning odor was present.Further investigation indicated the printed circuit board (pcb) had visible burn marks.A replacement pcb was ordered.The charring was isolated to the pcb.No fire was observed and no injury occurred.
Additional Manufacturer Narrative
Trending review determined no trend for the issue for the product.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.It is noted that during troubleshooting, the field service engineer was replacing the aspiration assembly head when the instrument was in the power on state.According to the removal and replacement procedure, rr-38, the aspiration module requires that the instrument be shut down.The cause of the spark and burnt smell is potentially due to hot swapping when the instrument was live.The cell-dyn sapphire service manual indicates to turn the system off before disconnecting the power cord and before servicing any electrical or internal components.Based on the information provided and the investigation performed, no deficiency was identified.Use error may have contributed to the complaint issue (plugging of an electrical connection when the instrument was in a power on state.).

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Common Device Name: 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: 16717659
• Report Number: 2919069-2023-00011
• Device Sequence Number: 7274933
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/10/2023

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: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown