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

Model Number	08H00-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2022
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.See mfr report ref# 2919069-2022-00023-00 for the adverse event.
Event or Problem Description
The vacuum accumulator of the cell-dyn sapphire analyzer had overflowed and leaked out to the table and floor causing the abbottlink power cord to get wet.Visible smoke was observed from the abbottlink power cord.The customer was wearing personal protective equipment.The field service engineer (fse) inspected the analyzer and found dried vacuum pump which caused the vacuum accumulator to overflow.The fse also replaced the power cord for the abbottlink firewall.No impact to patient management was reported.
Additional Manufacturer Narrative
Section b5-describe event or problem: updated with additional information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.
Event or Problem Description
Additional information received on 29aug2022.The analyzer had not been powered off when the fluid was being cleaned-up.
Additional Manufacturer Narrative
The customer reported the cell-dyn sapphire¿s vacuum accumulator level sensor failed, allowing fluid to flow into the vacuum and out into the table and floor, causing the abbottlink power cord to get wet.Visible smoke was observed from the abbottlink power cord.The field service engineer (fse) inspected the analyzer and replaced the vacuum accumulator.The fse also replaced the power cord for the abbottlink firewall.There was no damage to the facility reported.The investigation included review of product historical data and product labeling.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.Section 8 of the cell-dyn sapphire operator¿s manual provides information on potential hazards to personnel and potential damage to the laboratory environment.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire for serial number (b)(6) was identified.

• 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: 15276533
• Report Number: 2919069-2022-00024
• Device Sequence Number: 7002249
• 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,Followup
• Report Date (Section B): 10/21/2022

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: 08/01/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 10/12/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/15/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2010
• 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