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

Model Number ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem Mechanical Problem (1384)

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

Event Date 02/18/2023

Event Type  malfunction  

Event Description

The 3m autowaste pump of the customer's advia 2120i hematology system with single aspirate autosampler emitted smoke.The customer switched off the analyzer.There are no known reports of patient intervention or adverse health consequences due to this event.

Manufacturer Narrative

After becoming aware of smoke emitting from 3m autowaste pump of the advia 2120i hematology system with single aspirate autosampler, a siemens customer service engineer (cse) replaced the autowaste pump.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I WITH SINGLE ASPIRATE AUTOSAMPLER
• 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: 16456960
• MDR Text Key: 310414692
• Report Number: 2517506-2023-00078
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2023

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 SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2023
• Initial Date FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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