MAUDE Adverse Event Report: BECKMAN COULTER 5K STORAGE, POWER EXPRESS; RADIOASSAY, VITAMIN B12

Model Number 5K STORAGE, POWER EXPRESS

Device Problem Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

The failure mode is determined to be use error that caused injury on the finger.An error message was generated due to the shuttle cup not returned to its home position inside the stockyard.The system was paused due to the error at the time of incident.The operator was trying to remove unknown obstruction from level 3 of the 5k stockyard when the door cylinder closed on her fingers.The operator failed to follow power express storage modules information for use (ifu) error recovery procedures before attempting to remove the stuck object.The stuck tube was removed and the instrument resumed normal operations.The operator received unknown treatment for the finger injury.Per power express storage modules information for use (ifu), (b)(4) (october 2019), chapter 3, error recovery procedures, the caution statement states that, ¿even when a storage module is stopped or paused, the air system is still active and applies constant air pressure to the shuttle cups and the gripper arm assembly.This can cause unexpected movement of those parts, which creates a possible moving part or mechanical pinch hazard.Use caution when you resolve jammed object errors at a storage module.¿ ¿before you perform an error recovery procedure, confirm the module is stopped.When the module is stopped, the control panel turns red.¿ chapter 2, storage module procedures, page 2-3, states that ¿even when a storage module is stopped or paused, the air system is still active and applies constant air pressure to the shuttle cups and the gripper arm assembly.This can cause unexpected movement of those parts, which creates a possible moving part or mechanical pinch hazard.Use caution when you resolve jammed object errors at a storage module.¿ information not provided by customer.The beckman coulter internal identifier is (b)(4).

Event Description

Beckman coulter field service engineer (fse) reported that the operator injured their finger while removing obstruction from level 3 of the 5k stockyard in power express system.The operator¿s ring finger on the right hand was injured.The operator went to employee occupational health center and saw nurse.A x-ray was taken, and ice pack was applied on the injured area.The operator had a bruise, swelling and a fracture on the finger.The operator missed one day of work due to the injury.The operator was wearing personal protective equipment (ppe) at the time of incident.

• Brand Name: 5K STORAGE, POWER EXPRESS
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11456067
• MDR Text Key: 241935175
• Report Number: 2050012-2021-00013
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590673536
• UDI-Public: (01)15099590673536(11)170101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5K STORAGE, POWER EXPRESS
• Device Catalogue Number: B36361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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