MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While inspecting a leak on the laboratory's advia 2120i hematology system with dual aspirate autosampler, the customer was splashed on the face with a mixture of blood and rinse solution.The customer was not wearing safety goggles nor a face shield, and she did not know if the splatter hit her eyes.The customer subsequently had her blood tested after the event.There are no known reports of adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.The cse cleaned the centering collar and flushed the tubing connected to the centering collar.The manifold tubings were not pinched.After these actions were taken, the cse still observed that there was a slow leak while running samples.The cse changed the coupler manifold and tightened the needle and connector from the tubing at the needle to the selector valve.The leak was fixed after these actions were performed.The customer was not wearing facial protection (safety goggles nor a face shield) while inspecting the system leak.As per the advia 2120i hematology system operator's guide, "all products or objects that come into contact with human or animal body fluids should be handled, before and after cleaning, as if capable of transmitting infectious diseases.Wear facial protection, gloves, and protective clothing." the customer did not follow the instructions in the operator's guide and did not wear facial protection while operating the system.The cause of the customer being potentially splashed in the eye is use error.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.; dublin, ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 14137828
• Report Number: 2432235-2022-00114
• Device Sequence Number: 6253613
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown