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

Model Number ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Device Handling Problem (3265)

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

Event Date 02/18/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens has determined that the cause of the needlestick injury to the customer's finger on the advia 2120i hematology system with dual aspirate autosampler is the customer's technique when performing the centering collar maintenance on the instrument.The advia 120/ 2120/ 2120i hematology system operator's guide states the following: "to avoid personal injury and exposure to a potential biohazard, you must cover the needle with the red needle cover immediately after you remove the entering collar." the customer failed to follow the operator's guide instructions and did not cover the autosampler needle with the red needle stick cover after removing the centering collar.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that a clot was present in the centering collar on the advia 2120i hematology system with dual aspirate autosampler.They also reported that there was leakage near the centering collar.Upon performing maintenance on the centering collar, the customer sustained a needlestick injury to the finger.The customer did not require medical intervention and was tested for infectious diseases, which recovered as negative.There are no known reports of adverse health consequences due to the customer sustaining a needlestick injury while performing maintenance the centering collar on the advia 2120i hematology system with dual aspirate autosampler.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00154 on 12-apr-2018.Additional information (26-apr-2018): siemens further investigated the cause of the leak and clot in the centering collar of the advia 2120i hematology system with dual aspirate autosampler.Siemens determined that the clot in the centering collar of the system potentially contributed to the leak around the centering collar.Diluent, used to clean the needle and the centering collar, evacuates from the ports on the centering collar, which are connected to two valves, of the system.The ports were potentially occluded from lack of customer's maintenance, which possibly caused the leak.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7427202
• MDR Text Key: 105692447
• Report Number: 2432235-2018-00154
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• 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 DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR