MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT IMMUNOASSAY SYSTEM

Model Number	ADVIA CENTAUR XPT IMMUNOASSAY SYSTEM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that while troubleshooting the advia centaur xpt immunoassay system, the operator opened the waste fluidic drawer, and the liquid was sprayed on his forehead from the waste tubing, which was loosened.The operator stated that no liquid went to his eyes.The operator was wearing personal protective equipment (ppe) except the goggles.The customer cleaned the connections to the waste reservoir, emptied water trap and waste reservoir multiple time.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the instrument and observed that the liquid spilled from the waste transfer bellows pump, found and replaced the malfunctioned valves.The cse ran daily cleaning and quality control (qc) which recovered acceptably.Advia centaur xpt immunoassay system operator's guide safety instructions describes the basic safety precautions that should be followed when operating/troubleshooting the advia centaur xpt system.Siemens further evaluated the event and concluded that the malfunctioned valves of the waste bellows pump potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that while troubleshooting the advia centaur xpt immunoassay system, the operator opened the waste fluidic drawer, and the liquid was sprayed on his forehead from the waste tubing, which was loosened.The operator stated that no liquid went to his eyes.The operator was wearing personal protective equipment (ppe) except the goggles.After the operator was splashed, he went to the eyewash station and rinsed his forehead with water, and he did not seek any further medical intervention.There are no known reports of adverse health consequences due to the incident.

• Brand Name: ADVIA CENTAUR XPT IMMUNOASSAY SYSTEM
• Common Device Name: ADVIA CENTAUR XPT IMMUNOASSAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co; registration number: 8020888; dublin ; EI
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20770385
• Report Number: 2432235-2024-00318
• Device Sequence Number: 4387942
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141999
• 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): 11/25/2024

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 XPT IMMUNOASSAY SYSTEM
• Device Catalogue Number: 10711433
• 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: 11/11/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2017
• 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: Male