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

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc).The customer stated that the spill happened when routinely draining the waste container.This indicates that prior to draining the waste container the instrument was functioning as normal.The customer also stated that the waste container was installed back on the instrument after the spill, indicating that the spigot is sealing correctly and the waste container was functioning as intended.The worst case severity for this event is transient, self-limiting illness or injury that required a general check-up, with no major acute management needed.The customer sustained local irritation to their leg and foot with no report of any long-term injury.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that waste spilled on their leg and foot while they were manually emptying the waste from the laboratory's advia 2120i hematology system with dual aspirate.The customer was wearing personal protective equipment (ppe) at the time of the event.The customer washed off the area where the waste spilled and reported that their skin was red.The customer went to employee health and was not treated for biohazard exposure.There are no known reports of adverse health consequences due to this event.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL 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: 16274800
• Report Number: 2432235-2023-00042
• Device Sequence Number: 5949813
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162977
• 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): 01/31/2023

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: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Device Catalogue Number: 11219529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2017
• 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