MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument observed smoke being emitted from the instrument.The laboratory was not evacuated.The instrument was powered down by the customer.There were no reports of adverse health consequences due to the smoke emitted from the instrument.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse determined that the smoke was emitted from the alternating current (ac) power receptacle.The cse determined that a blockage in the drain line allowed water to overflow from the reagent compartment, which came in contact with the power receptacle.The cause of the smoke being emitted from the instrument was due to water contacting the ac power receptacle.The cse replaced the power receptacle and verified proper functioning of the drain pinch valves.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords co dublin, ; EI
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3864539
• MDR Text Key: 4568517
• Report Number: 2432235-2014-00371
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 7 YR
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2007
• 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