MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP REFURB INSTRUMENT

Model Number	ADVIA CENTAUR XP REFURB INSTRUMENT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The operator contacted the siemens customer care center (ccc) and informed that a connection of the bottle was broken.The operator temporarily secured the connection and stated that fluid was entering the bulk bottle.The ccc dispatched a siemens customer service engineer (cse) to the customer site.The cse performed service and replaced the waste bottle assembly to resolve the issue.The cse verified the operation of the advia centaur xp, and there were no leaks and no instrument errors.Siemens evaluated the event and determined that the cause of the leak is due to a broken fitting at the tubing connection.The operation of the advia centaur xp has been verified, and the instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
The operator noticed that a connection from the advia centaur xp waste bottle was broken and caused waste fluid to leak on the floor.The operator cleaned the leak and got some fluid on their skin.The skin became red and irritated, and the operator did not seek medical attention and claimed no serious harm.There are no reports of patient intervention or adverse health consequence due to the leak and exposure to waste fluid.

• Brand Name: ADVIA CENTAUR XP REFURB INSTRUMENT
• Common Device Name: ADVIA CENTAUR XP REFURB INSTRUMENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9111344
• Report Number: 2432235-2019-00334
• Device Sequence Number: 14246376
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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 XP REFURB INSTRUMENT
• Device Catalogue Number: 10471899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1