MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that cuvette washer a probe travel was not locked on the dimension vista 500 instrument.While troubleshooting this matter, the customer communicated that an operator was splashed with bleach.The operator reset the instrument.With siemens remote assistance, the operator located cuvette wash blocks a and aa, removed and cleaned cuvette washer a probe, and cleaned bushing.The operator found a green contaminate in the tubing, cleaned the tubing with a cotton tipped applicator and water, flushed cuvette washer probe with bleach and water, and ran check 1 on cuvette washer, which passed.Lastly, the operator reset the instrument.The operator was not wearing adequate personal protective equipment, such as a face shield and googles, while addressing the tubing contamination.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that cuvette washer a probe travel was not locked on the dimension vista 500 instrument.While troubleshooting this matter, the customer observed a green contaminate in the tubing.In attempt to bleach the tubing, an operator was splashed with bleach.The operator wiped her face, rinsed her eyes and visited emergency room, where they followed the needle exposure protocol.The operator was tested for human immunodeficiency virus (hiv), which recovered negative.No treatment was required.There are no known reports of adverse health consequences due to this event.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 20241477
• Report Number: 2517506-2024-00229
• Device Sequence Number: 12752893
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: (01)00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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
• Device Catalogue Number: 10488217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female