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

Model Number ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Leak/Splash (1354)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).A blockage was found in the centering collar of the advia 2120i hematology system with dual aspirate autosampler, which caused aspirated fluid to be sprayed upward rather than through the needle.The customer was not wearing proper personal protective equipment (ppe) when investigating this issue, which is why the aspirate went into the customer's eye.Siemens is investigating the issue.

Event Description

The customer was splashed in the eye with mixture of blood and reagent after opening the autosampler safety shield of the customer's advia 2120i hematology system with dual aspirate autosampler.The customer had noticed that the samples coming out of the system were contaminated with blood and reagent, which is what prompted the customer to open the safety shield.A safety visor was not readily available to wear when investigating the problem, leading to aspirate going into customer's eye.The customer followed first aid protocol by washing their eye with warm water and went to the emergency department.The customer was put on a 28 day course prophylactic treatment for blood borne viruses as a precautionary measure.There are no known reports of adverse health consequences due to this event.

Manufacturer Narrative

Siemens filed the initial mdr on 15-oct-2021.Additional information ((b)(6) 2021): the customer was not wearing facial protection when clearing a blockage in the centering collar of the advia 2120i hematology system with dual aspirate autosampler.As per the advia 2120i hematology system operator's guide "all products or objects that come in contact with human or animal body fluids should be handled, before and after cleaning, as if capable of transmitting infectious diseases.Wear facial protection, gloves, and protective clothing.".The cause of the aspirate entering the customer's eye was a use error.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 12639460
• MDR Text Key: 276652110
• Report Number: 2432235-2021-00254
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (y/n): N
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 11219529
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1