MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION

Model Number	APTIO AUTOMATION
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A laboratory engineer was attending to a report of a leak around the aptio automation system when a sysmex cs-5100 instrument dumped its waste into the aptio automation system waste drain.The drain line from the sysmex cs-5100 was not properly secured into the aptio automation system waste drain and as a result the waste splashed the engineer in the eye.The engineer used a strap to secure the waste line from the sysmex cs-5100 to the waste drain of the aptio automation system.The engineer was reportedly not wearing eye protection.The engineer reportedly had the eye checked and cleaned.The engineer reportedly had a problem of an eye scorch for some days after the event.The cause of the biohazardous exposure was an unsecured waste line at the waste drain of the aptio automation system and the operator not wearing eye protection.
Event or Problem Description
The customer contacted siemens to report that one person in the lab was exposed to biohazardous waste while inspecting a leak around the aptio automation system.There are no known reports of patient intervention or adverse health consequences due to the exposure to biohazardous waste.

• Brand Name: APTIO AUTOMATION
• Common Device Name: APTIO AUTOMATION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8764547
• Report Number: 2517506-2019-00278
• Device Sequence Number: 11404599
• Product Code: LXG
• UDI-Device Identifier: 00630414596754
• UDI-Public: 00630414596754
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

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: APTIO AUTOMATION
• Device Catalogue Number: 10713760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1