MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.Quality controls for co2 were in acceptable range.The customer replaced the aliquot probe and sample probe, and then had an alignment failure for shuttle 2.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse cleaned the alignment points for shuttle 2 and successfully performed the auto-alignment for shuttle 2.The cse ran a correlation sample for co2 and received sample probe clog detect message.The cse performed diagnostic checks for sample probe, which was acceptable.The cse also performed a system quick check, reset the analyzer and ran quality control for co2.The sample probe produced an error.The cse determined that the motor to spline coupler was broken.During removal of the sample arm assembly, the tubing fittings were damaged.During the follow-up visits, the cse replaced the damaged tubings, primed fluid lines and found the acrylic manifold leaks.The cse replaced the manifold and printed circuit board assembly.The sample arm was failing vertical titration.The vertical drive splines for the sample arm were worn and not aligned, while the sample clog detect was ruptured.The cse replaced the vertical drive spline coupler and motor, tubings and replaced the vertical drive motor again as it failed vertical titration.The cse primed the fluid lines but the sample probe clog detect ruptured.The cse replaced the sample probe clog detect and was unable to align the sample arm.The cse replaced the sample and integrated multi-sensor technology (imt) arm assemblies.The cse successfully aligned the sample and imt arms, primed fluid lines and verified that there were no leaks.The cse ran check1 and system quick check, reset the analyzer, verified temperatures, and ran quality controls, which were acceptable.The cause of the discordant, falsely low co2 result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
A discordant, falsely low carbon dioxide (co2) result was obtained on one patient sample on a dimension vista 500 instrument.The discordant result was not reported to the physician(s).The sample was repeated twice on an alternate dimension vista instrument, resulting higher both times.The results obtained on the alternate dimension vista instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low co2 result.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7637173
• Report Number: 2517506-2018-00391
• Device Sequence Number: 11311455
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1