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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was at the customer site.The event happened when the cse was checking the waste reservoir connectors after removing the waste reservoir.The direct waste disposal connector disconnected, and the cse was splashed.Siemens is investigating this issue.
Event or Problem Description
During troubleshooting of an advia centaur xp instrument, the siemens customer service engineer (cse) was splashed in the face with waste fluid.The cse was wearing a gown and gloves but not protective eye-ware.The cse went to the emergency room where infectious disease testing was carried out, and resulted negative.The cse did not receive treatment.
Additional Manufacturer Narrative
The initial mdr 2432235-2017-00564 was filed on october 20th, 2017.Additional information (11/15/2017): a siemens headquarter support center (hsc) specialist evaluated the event.The fittings on the waste reservoir click into place when properly seated; therefore, it is inconclusive how the fittings became disconnected.There is a potential that they became disconnected in the act of performing troubleshooting.To date, all infectious disease testing results for the engineer resulted negative.Updated to reflect the conclusion provided above.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 6964828
• Report Number: 2432235-2017-00564
• Device Sequence Number: 1324702
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1