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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The customer washed her face and rinsed out her mouth.Siemens is investigating the issue.
Event or Problem Description
As the customer¿s advia 2120i hematology system was performing automatic closed tube sampling (acts), fluid sprayed out of the acts area onto the customer¿s face and mouth.The acts door was open.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00015 on 24-jan-2024.Additional information (25-jan-2024): the operator was splashed with sheath rinse and was not exposed to biohazardous material.The customer was wearing gloves and goggles but was not wearing a face shield.Siemens is investigating the issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00015 on 24-jan-2024.Siemens filed the first supplemental mdr 2432235-2024-00015_s1 on 22-feb-2024.Additional information (07-feb-2024): as per the advia 2120i operator's guide, "all products or objects that come in 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".In this case the operator was wearing eye protection but not facial protection.Additional information (04-mar-2024): it is not known why the spray occurred but the autosampler door would have had to have been open at the time of the incident for an operator to be sprayed.The autosampler has a switch that will cut off the power to the autosampler when the door is opened in order to avoid injury.This switch would have to have been bypassed for this event to have occurred.The cause of the event is use error.The investigation findings and investigation conclusions codes in section h6 were updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• 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: 18574882
• Report Number: 2432235-2024-00015
• Device Sequence Number: 18371404
• Product Code: GKZ
• UDI-Device Identifier: 00630414019789
• UDI-Public: 00630414019789
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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 SINGLE ASPIRATE
• Device Catalogue Number: 11219530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 01/25/2024; 02/07/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/22/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female