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

Model Number DIMENSION VISTA 500

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

The customer reported that a small amount of liquid from the dimension vista 500 instrument splashed onto an operator¿s face and eye as he was clearing a jammed vessel.The operator subsequently flushed his face and eyes with water.The customer stated that there was no burning, itching, or other irritations due to the liquid splash.Additionally, no medical intervention was required.There are no known reports of adverse health consequences due to the event.

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that the luminescent oxygen channeling immunoassay (loci) reader pressure transducer malfunctioned on the dimension vista 500 instrument.It was determined that there was a jammed vessel in the waste tubing.An operator removed the jammed loci vessel in the waste tubing, and while doing so, liquid from the instrument splashed onto his face and eye.The customer indicated that there was no irritation from this incident.After removing the jammed vessel in the waste tubing, the operator verified that the vessels were dropping into the tubing and reset the instrument.The instrument is performing according to specifications.The dimension vista systems operator¿s guide indicates ¿the dimension vista system processes clinical laboratory specimens which are potential biohazards.It is important to follow standard biohazard protection laboratory practice when handling these specimens or when operating, maintaining, or troubleshooting the instrument.Always follow procedures exactly, performing every step-in sequence.Be sure to pause the instrument when specified to prevent probes from moving while performing a procedure.All materials that contact patient samples should be considered potential biohazards.Treat them according to local biohazard handling and disposal procedures.¿ the customer indicated that the operator was wearing personal protective equipment at the time of the event; it is unknown how the operator was exposed to liquid from the instrument while wearing personal protective equipment.

• Brand Name: DIMENSION VISTA 500
• Type of Device: 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 #: 1226181; brookfield NY
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18495118
• MDR Text Key: 333208228
• Report Number: 2517506-2024-00016
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: 00630414949581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Device Catalogue Number: 10284473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male