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

Model Number	ADVIA CENTAUR CP
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported cuvette jam on the advia centaur cp instrument.The customer noticed smoke emitted from back of the cuvette hopper area of the instrument and burning smell.The customer subsequently turned off the instrument.The customer stated that there were no visible flames associated with the event.There are no known reports of adverse health consequences due to the incident.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported cuvette jam on the advia centaur cp instrument.The customer noticed smoke emitted from back of the cuvette hopper area of the instrument and burning smell.The customer immediately turned off the instrument and computer.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse attempted to replace probe printed circuit board (pcb), firmware download to new pcb failed, reagent probe failed to move as the motor encoder was not seen by the pcb.Then, the cse swapped probe y cable to board, replaced z motor and board, pcb board, downloaded firmware, however, reagent arm did not move.The cse replaced two malfunctioned pcb boards, ran multiple functional tests and repeated quality control (qc) twice, which recovered acceptably.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr (b)(4) on 28-mar-2024.Additional information (08-apr-2024): in addition to the service actions mentioned in the initial report, a siemens customer service engineer (cse) replaced several components, including the x-movement pulley, cable, reagent probe, and probe sensor boards, and initialized the reagent probe.Through sequential service method testing and quality control (qc) procedures, the instrument was determined to be fully operational.The service activities mentioned in this report and the initial report resolved the malfunction.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP
• Common Device Name: ADVIA CENTAUR CP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18993108
• Report Number: 2432235-2024-00060
• Device Sequence Number: 7605227
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/17/2024

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 CP
• Device Catalogue Number: 10309710
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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