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

Model Number ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Leak/Splash (1354)

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

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that as she was performing the daily maintenance for the lab's advia 2120 hematology system with dual aspirate autosampler (s/n: (b)(4)), waste fluid splashed onto her mouth area while she was reconnecting the vacuum line onto the waste container.The customer was not wearing a face shield nor protective eyewear when the incident occurred.The customer cleaned and disinfected the skin around her mouth.The customer did not ingest the potentially biohazardous material and there were no other facial areas exposed.The customer will be tested for (b)(6).The customer will not seek further medical attention or treatment.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

As the customer was performing the daily maintenance for the lab's advia 2120 hematology system with dual aspirate autosampler (s/n: (b)(4)), waste fluid splashed onto her mouth area while she was reconnecting the vacuum line onto the waste container.There are no known reports of medical intervention or adverse health consequences due the customer being splashed on the mouth by waste fluid.

• Brand Name: ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; swords, co., dublin, ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 8697443
• MDR Text Key: 203537847
• Report Number: 2432235-2019-00203
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2019

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 2120 WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10313419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2007
• 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