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

Model Number 5K STORAGE, POWER EXPRESS

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Date of birth or age, gender,weight, race, ethnicity: customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.An adverse event that occurred on (b)(6) 2019 was reported to a beckman coulter field service engineer (fse) while on assignment at a customer site on (b)(6) 2019.While correcting a transfer error of a tube from the outer loading arm to the shuttle vessel, a staff member grabbed from behind through the still open rear sliding door to remove the incorrectly placed tube.The door suddenly closed, trapping their hand.The customer reported that they had their hand trapped in power express 5k storage while trying to remove incorrectly placed tube.The failure mode use error.The injured staff did not perform error recovery as per procedure.Per power processor ifu (pn-b01683a), chapter 4 error recovery procedure, caution statement states that, ¿even when the system is in pause mode, the air system is still active and applying a constant air pressure to various assembly components.This may cause unexpected movement of assembly components in various power processor modules, creating a possible moving part or pinch hazard.¿ beckman coulter internal identifier: (b)(4).

Event Description

An adverse event was reported by a customer to beckman coulter.While correcting a transfer error of a tube from the outer loading arm to the shuttle vessel, a staff member grabbed from behind through the still open rear sliding door to remove the incorrectly placed tube.The door suddenly closed, trapping their hand.The customer reported had their hand trapped in power express 5k storage while trying to remove incorrectly placed tube.

• Brand Name: POWER EXPRESS
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 9296804
• MDR Text Key: 167586816
• Report Number: 2050012-2019-01131
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590673536
• UDI-Public: (01)15099590673536(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2019

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: CHEMRA@BECKMAN.COM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1