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 Sparking (2595)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The advia 2120i hematology system was powered off.A siemens customer service engineer (cse) was dispatched to the customer¿s site to inspect and troubleshoot the issue.Siemens is investigating the issue.

Event Description

One of the three tubes of the staining fluid reservoir of the advia autoslide of the customer¿s advia 2120i hematology system came off and got caught in the system's printer connector board.The printer subsequently sparked.There are no known reports of injury, delay in testing, nor adverse health consequences due to this event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00104 on 19-may-2023.Additional information (26-apr-2023): as mentioned in the initial report, a siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse confirmed that the staining fluid tube came off and was leaking.Then, the cse reconnected and reinforced the tube and replaced the printer.Lastly, the cse confirmed normal operation in slide creation.Additionally, the affected instrument was determined to be an advia 2120i hematology system with dual aspirate.The instrument is performing according to specifications.No further evaluation of this device is required.The investigation findings and investigation conclusions codes in section h6 were updated to reflect the additional information.

• 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: 16962516
• MDR Text Key: 315862302
• Report Number: 2432235-2023-00104
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 10404381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2011
• 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