MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

Model Number	ADVIA CENTAUR XP
Medical Device Problem Codes	Leak/Splash (1354); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they heard a beeping sound from a uninterruptible power supply (ups) that was connected to an idle advia centaur xp instrument.Subsequently, the customer pressed the power button on the ups and determined that sparks and smoke emitted from the advia centaur xp instrument¿s power supply cord.The customer disconnected the system from the ups and outlet and removed all onboard reagents.Patient results were not impacted or delayed.There are no known reports of adverse health consequences or required medical attention due to the event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report that the advia centaur xp instrument¿s power cord burned.The customer disconnected the instrument from the uninterruptible power supply (ups) and outlet and removed all onboard reagents.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse determined the reagent probe 1 (rp1) rinse bowl shifted, causing the rp1 probe to dispense fluid down the side of the instrument and into the power inlet plug area.This caused a short circuit, sparks, and smoke.The cse replaced the power cord and the power inlet assembly in the system and verified the power.The instrument was rebooted, and a daily cleaning was performed.Liquid dispensing into the power inlet area, leading to an electrical short circuit, contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 20606252
• Report Number: 2432235-2024-00279
• Device Sequence Number: 20697644
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/04/2024

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 CENTAUR XP
• 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: 10/13/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2013
• 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