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

Model Number ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The advia 2120/2120i operators guide, section 5, page 19, states "caution when performing this procedure, do not use force on the syringe at any time." step 5 in the procedure states "gently push the plunger on the cleaning syringe to flush the bleach solution through the rbc flowcell." if force is applied to the syringe while backflushing the flowcell, the tubing can come off of the syringe or fitting and bleach may spray from the connection.Additionally the procedure says "wear facial protection, gloves, and protective clothing." it is unknown if the customer was wearing personal protective equipment (ppe) at the time of the event.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Bleach solution splashed into the customer's eye as he was performing a reverse wash of the flow cell on the lab's advia 2120 hematology system with single aspirate autosampler.The customer rinsed his eye out with water.No further medical treatment was necessary.There are no reports of adverse health consequences due the customer being splashed in the eye while performing a reverse wash of the flow cell on the lab's advia 2120 hematology system with single aspirate autosampler.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2020-00256 on 27-mar-2020.Additional information (14-apr-2020): the customer was wearing gloves, but was not wearing goggles, at the time of the event.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown, ny
• MDR Report Key: 9891576
• MDR Text Key: 208201475
• Report Number: 2432235-2020-00256
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K102644
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10316162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1