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 01/28/2015

Event Type  malfunction  

Event Description

Smoke emission was detected from the advia centaur xp direct water feed tubing.The fire department was contacted, who checked the laboratory.There was no report of injury to staff, damage to property or impact to patients.

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 the 2-way solenoid valve malfunctioned.The 2-way solenoid valve is connected to the direct water feed tubing.The cse determined the 2-way solenoid valve over-heated and caused the smoke emission.The cse replaced the 2-way solenoid valve.The instrument is performing within specifications.Further evaluation of the device is not 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: 4533313
• MDR Text Key: 17574544
• Report Number: 2432235-2015-00089
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2015
• 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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2010
• 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