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

Model Number 08H00-01

Device Problem Unintended Electrical Shock (4018)

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

Event Date 07/31/2022

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.See mfr report ref# 2919069-2022-00024-00 for the smoke event.

Event Description

The vacuum accumulator of the cell-dyn sapphire analyzer had overflowed and leaked out to the table and floor.While cleaning up the fluid, the lab assistant customer felt a small shock.The customer stated no medical treatment was needed and she completed her shift.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.No medical treatment needed from the electric shock.

Manufacturer Narrative

Section b5-describe event or problem: updated with additional information from 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 Description

Additional information received on 29aug2022.The analyzer had not been powered off when the fluid was being cleaned-up.

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.The customer stated while the lab assistant was cleaning up the fluid, the lab assistant felt a small shock.The customer stated no medical treatment was needed and the lab assistant was able to complete her shift.The lab assistant was wearing personal protective equipment.However, the analyzer had not been powered off when the fluid was being cleaned up.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, product labeling and cft (cross functional team) meeting.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.The cft (cross functional team) meeting determined that use error contributed to the issue as the operations manual states, ¿keep liquids away from all electrical or communication component connectors.Do not touch with wet hands any switches or outlets.¿ based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire for serial number 43060az was identified.

• Brand Name: CELL-DYN SAPPHIRE 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: 15276522
• MDR Text Key: 298411099
• Report Number: 2919069-2022-00023
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051215
• 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,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Female