MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center and reported that there was no rinsing needle in the sampling mode.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse swapped vacuum measure on the pneumatic board and determined that there was no unified fluids circuit (ufc) vacuum.The cse replaced the ufc, compressor heads, compressor tubing, vaccushield and hydrophobic filter, waste manifold, and tubings.The cse tested connectors on the pneumatic chassis and ran quality controls, recovering acceptably.The cse reported that he was splashed with bleach when he pushed bleach through the ufc liquid separator chamber to ufc waste line to unclog the ufc pathway.The cse reported that he was wearing protection glasses.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
While troubleshooting the clogged unified fluids circuit (ufc) pathway on an advia 2120i hematology system with dual aspirate autosampler, a siemens customer service engineer (cse) was splashed in the eye with bleach.The cse rinsed his eye with water and did not seek additional medical intervention or treatment.There are no known reports of adverse health consequences due to the bleach that splashed into the cse's eye.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7669194
• Report Number: 2432235-2018-00286
• Device Sequence Number: 806160
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1