MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number AUTOMATE 2550

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/20/2022

Event Type  Injury  

Event Description

The customer reported an operator's hand was caught at the back of the automate on the secondary tube feed.The operator obtained a fracture to index and middle fingers of their left hand.The operator applied an ice pack and bandaging.The operator attended a&e (emergency room) for assessment and x-ray.

Manufacturer Narrative

Beckman coulter field service engineer (fse) evaluated the automate instrument, and re-enacted the location of the customer's hand at the time of the injury in the tube supply unit whilst the instrument was powered down.The fse determined that a tube blockage in this section of the automate was attempted to be recovered whilst the system was still powered on and active.When the operator identified that a tube jam occurred in the inlet section of the tube hopper, the compressor was still under pressure and the piston still exerting a force on the tube.The automate ifu indicates to depressurize the compressor first and raises a warning "do not try to remove any tube jammed without depressurizing the compressor first." the cause of this issue is attributed to use error as the operator did not respect the prescribed instruction to depressurize the compressor while attempting to remove the jammed tube and the piston, now free from resisting obstacle, trapped the finger of the user.No further details were provided on the customer's injury.Initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).

• Brand Name: AUTOMATE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen bavaria CA 81379 ; GM 81379
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 15809732
• MDR Text Key: 303798563
• Report Number: 3006655511-2022-00004
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 15099590364083
• UDI-Public: (01)15099590364083(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AUTOMATE 2550
• Device Catalogue Number: ODL25255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female