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

Model Number ADVIA CENTAUR CP

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: 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: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 18993108
• MDR Text Key: 339142230
• Report Number: 2432235-2024-00060
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1