MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP INSTRUMENT

Model Number	ADVIA CENTAUR XP INSTRUMENT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported that they were splashed in the eye with fluid while wearing personal protective equipment (ppe) on an advia centaur xp instrument.The customer contacted the siemens customer care center (ccc) and a customer service engineer (cse) was dispatched to the site to inspect the instrument.The monthly cleaning procedure was failing due to a ¿vacuum high¿ and ¿water reservoir low¿ error.The cse verified these issues.The cse replaced the water reservoir manifold and the incoming (large) male water connector.The analyzer was tested and the instrument was fully operational upon departure.No further instrument investigation is required.
Event or Problem Description
A customer was splashed in the eye with fluid while wearing personal protective equipment (ppe).This occurred while troubleshooting a monthly cleaning procedure on an advia centaur xp instrument.The source of the fluid was unknown and an eye washer was used for 15 minutes.Customer was evaluated by their employee health team.It was confirmed that there was no impact to patients and no delays in results.There were no known reports of patient intervention or adverse health consequence due to this event.

• Brand Name: ADVIA CENTAUR XP INSTRUMENT
• Common Device Name: ADVIA CENTAUR XP INSTRUMENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co; registration number: 8020888; dublin ; EI
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 18221847
• Report Number: 2432235-2023-00311
• Device Sequence Number: 20251784
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041133
• 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): 11/28/2023

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 CENTAUR XP INSTRUMENT
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/28/2023
• Date Device Manufactured: 09/28/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown