MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE 2500; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number REC KNIFE HOLDER

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

Please refer to investigation results section for investigation details.Investigation indicates that the beckman coulter (bec) field service engineer's (fse) hand slipped and cut the thumb while cleaning the decapper blade.There is no report of injury to the ligaments, tendons, and bones.The fse went to the doctor¿s office for the treatment and received suture on the thumb to recover from the injury.The failure mode is determined to be use error.There is no evidence of a automate system malfunction.Information not provided by customer.Initial reporter name and address: initial reporter telephone number is (b)(6).The beckman coulter internal identifier is (b)(4).

Event Description

Beckman coulter (bec) customer support manager reported an injury to the field service engineer (fse) while cleaning the decapper blade in the automate system.The fse cut his thumb which required suture by as doctor.The fse did not take any prescription or over the counter medication due to this injury.The fse missed seven (7) days of work due to this incident.It is unknown if the fse was wearing personal protective equipment at the time of the incident.

• Brand Name: AUTOMATE 2500
• 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 81379 ; GM 81379
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 15933253
• MDR Text Key: 304998180
• Report Number: 3006655511-2022-00005
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 15099590362119
• UDI-Public: (01)15099590362119(11)170907
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REC KNIFE HOLDER
• Device Catalogue Number: ODL20508
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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