MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE 2550 LAB INSTRUMENT; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number AUTOMATE 2550

Device Problem Mechanical Jam (2983)

Patient Problem Crushing Injury (1797)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

A beckman coulter field service engineer (fse) went onsite on (b)(4) 2018 and evaluated the instrument.The fse did not find any malfunction of the device.The operator failed to depressurize the system before attempting to remove the blockage.The instructions for use clearly state to depressurize the compressor in case of a tube jam.(b)(4).

Event Description

On (b)(6) 2018, a user incorrectly tried to remove tubes that were blocked/jammed from inside the automate 2550 lab instrument.The user's thumb became "blocked" by the roller resulting in a bruised thumb.The user received a medical review and prescription anti-inflammatory treatment.

• Brand Name: AUTOMATE 2550 LAB INSTRUMENT
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str 44; muenchen bayern 81379 ; GM 81379
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 7710877
• MDR Text Key: 114726453
• Report Number: 3006655511-2018-01000
• 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: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2018

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: AUTOMATE 2550
• Device Catalogue Number: ODL25255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/03/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other