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

Model Number ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE

Device Problem Device Handling Problem (3265)

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

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that an operator was exposed to advia ez wash solution while performing maintenance on the advia 2120i hematology system with single aspirate when the solution bottle slipped.The customer did not provide details on how the solution bottle slipped or how the operator was exposed to the advia ez wash solution when the operator was wearing personal protective equipment (ppe).The advia 120/advia 2120/advia 2120i hematology systems operator's guide advises operators' to "wear facial protection, gloves, and protective clothing" when performing maintenance on the system.The cause of the operator's exposure to the advia ez wash solution is unknown.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

An operator of an advia 2120i hematology system with single aspirate was exposed to advia ez wash solution while performing maintenance on the system; the advia ez wash solution splashed onto the customer's face and eye when the solution bottle slipped.The operator rinsed her eye and sought ophthalmic consultation.The physician(s) prescribed a treatment of antibiotic eye drops, lubricant moisturizing eye drops, eye drops for dry eyes and vitamin a ointment for a month to the operator.There are no known reports of adverse health consequences due to the operator's exposure to advia ez wash solution.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00370 on (b)(6) 2018.Additional information (05-oct-2018): the customer clarified that the operator was exposed to advia ez wash solution when the bottle slipped from the operator's hand.The bottle fell and hit the table.Due to this, contents from the bottle splashed onto the operator's face and eye.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7935851
• MDR Text Key: 125127728
• Report Number: 2432235-2018-00370
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414019789
• UDI-Public: 00630414019789
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE
• Device Catalogue Number: 11219530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR