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

Model Number 5K STORAGE POWER EXPRESS

Device Problem Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

The customer stated that two (2) operators tried to clear an obstruction inside the 1st floor of the 5k stockyard system by making an improper maneuver when the shuttle suddenly started and hit one of the operator's fingers.The operator¿s finger was fractured.There was no cut, bruise, or swelling due to the injury.The operator did not seek any medical treatment.The operator did not receive any prescription medication.The operator missed 12 days of work due to the injury.A beckman coulter field service engineer (fse) evaluated the event and could not identify any system or hardware malfunction.The fse observed that no parts were damaged and the system was in "error mode" at the time of the event.The fse stated that the injured operator went to receive first aid two days after the event.A bandage was applied to the finger.No further information was provided.The cause of the issue is attributed to use error as the customer did not use the caution before attempting to clear the obstruction.The customer failed to follow the power express storage module ifu (information for use).Per power express storage module ifu (information for use), (b)(4), chapter 3, error recovery procedure, 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.¿ age, weight and ethnicity: information not provided by customer.(b)(6).The beckman coulter internal identifier is (b)(4).

Event Description

The customer reported that a lab operator was injured while trying to clear the obstruction inside the 1st floor of the 5k stockyard in power express system.The customer stated the operator¿s finger was fractured from being hit by the shuttle of the system.The beckman coulter field service engineer (fse) stated the operator received first aid treatment and applied bandage on the finger.There was no cut, bruise, or swelling due to the injury.The operator did not seek further medical treatment.The operator did not receive any prescription medication.The operator missed twelve (12) days of work due to the injury.It is unknown if the operator was wearing personal protective equipment at the time of incident.No patients were involved in this event.

• 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: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 14291126
• MDR Text Key: 290944221
• Report Number: 2050012-2022-00023
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590673536
• UDI-Public: (01)15099590673536(11)140501
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140496
• 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
• Report Date: 05/04/2022

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
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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