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

Model Number ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE

Device Problem Leak/Splash (1354)

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

Event Date 01/07/2023

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted a siemens customer care center (ccc).The customer stated that the spill happened when routinely draining the waste container.This indicates that prior to draining the waste container the instrument was functioning as normal.The customer also stated that the waste container was installed back on the instrument after the spill, indicating that the spigot is sealing correctly and the waste container was functioning as intended.The worst case severity for this event is transient, self-limiting illness or injury that required a general check-up, with no major acute management needed.The customer sustained local irritation to their leg and foot with no report of any long-term injury.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that waste spilled on their leg and foot while they were manually emptying the waste from the laboratory's advia 2120i hematology system with dual aspirate.The customer was wearing personal protective equipment (ppe) at the time of the event.The customer washed off the area where the waste spilled and reported that their skin was red.The customer went to employee health and was not treated for biohazard exposure.There are no known reports of adverse health consequences due to this event.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.; dublin, ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16274800
• MDR Text Key: 309071696
• Report Number: 2432235-2023-00042
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162977
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• 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 DUAL ASPIRATE
• Device Catalogue Number: 11219529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2017
• 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