MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME

Model Number ATELLICA SAMPLE HANDLER PRIME

Device Problem Mechanical Jam (2983)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

The operator's sustained a bruise to the hand while troubleshooting the atellica sample handler prime magline.The operator did not require medical intervention.There are no known reports of patient intervention or adverse health consequences due to the sustained bruise.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center (ccc).Siemens assisted the operator with troubleshooting instructions.The operator did not follow the steps provided and tried to remove two pucks from the magline to clear an error jam and sustained a bruise to the hand.The operator wore no gloves or personal protective equipment (ppe) on the day of the event and noted no exposure to biohazardous materials.Siemens is investigating the event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2022-00075 on 15-mar-2022.Additional information (25-mar-2022): siemens reviewed the information provided and determined the troubleshooting performed by the operator resolved the issue.However, the operator did not follow proper instructions.The online help guide, section 17, "clearing carrier jams on the atellica magline transport" provides troubleshooting instructions and a cautionary note "do not remove the carriers from the atellica magline transport.The carriers have strong magnets in the base and handling them in close proximity to metal objects can result in a body part being pinched between the carrier and the metal object.Only authorized service personnel should handle carriers." step 6 of the same procedure instructs the user to "slide the carriers apart manually on the atellica magline transport to clear the jam condition." siemens determined the operator could have avoided the injury by following the instructions provided by siemens and included in the online help guide.Siemens identified no maintenance or systemic issue with the atellica sample handler prime magline.The system is fully operational.No further evaluation of the device was required.Siemens updated section h6 (investigation findings and investigation conclusions) to include new codes.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Type of Device: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 13772152
• MDR Text Key: 287208079
• Report Number: 2432235-2022-00075
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161954
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA SAMPLE HANDLER PRIME
• Device Catalogue Number: 11069001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• 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
• Patient Sex: Female