MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 CHEMISTRY SYSTEM

Model Number	ADVIA 1800 CHEMISTRY SYSTEM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc).Siemens dispatched a customer service engineer (cse) to the customer site.Siemens noted the liquid was dry and caused damage to the power supply and reagent reaction bath (rrv) controller.Siemens replaced the power supply, adjusted rrv, and verified the system's operation.Siemens is investigating the event.
Event or Problem Description
The customer spilled liquid on the advia 1800 chemistry system and alleged the feeling of current within the body while cleaning the spill.The customer contacted the siemens customer care center (ccc), and siemens instructed the customer to power off the system.There are no reports of patient intervention or adverse health consequences due to the liquid spill.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00183 on 15-jun-2022.Additional information (11-jul-2022): siemens noted that a siemens customer service engineer (cse) replaced the power source and rrv (rotary reaction vessel) controller and adjusted the rrv to return the advia 1800 chemistry system to operation.The potential cause of the event is the operator spilling liquid on the system.The system performs as specified and requires no further evaluation.Additional information (13-jul-2022): the customer provided additional information regarding the event.There was no damage to other property.Only the advia 1800 chemistry system was affected.The liquid that spilled on the system was identified as diluted chlorine.The spill occurred on the system and on the floor and did not cause cross contamination or a slip, trip or fall.The operator was wearing personal protective "equipment" and did not seek medical assistance.The customer noted no delay in patient testing and result reporting because they have a backup advia 1800 chemistry system.Siemens updated section h6 (investigation findings and investigation conclusions) to include new codes.

• Brand Name: ADVIA 1800 CHEMISTRY SYSTEM
• Common Device Name: ADVIA 1800 CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 14700220
• Report Number: 2432235-2022-00183
• Device Sequence Number: 17815635
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K990346
• 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
• Report Date (Section B): 07/28/2022

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 1800 CHEMISTRY SYSTEM
• Device Catalogue Number: 10315183
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2017
• 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