MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number TN, LH780 ANALYTICAL STATION

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

Service was not scheduled to visit the site.The information provided is not enough to define whether the event occurred because of user error or an instrument malfunction.The operators of the instrument at the site will trained/retrained on how to handle the waste container and it's respective tubing.Per coulter lh 780 system instructions for use pn 773022be (january 2013): beckman coulter, inc.Urges its customers to comply with all national health and safety standards such as the use of barrier protection.This may include, but it is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.Bec internal identifier - (b)(4).

Event Description

The customer reported that a waste hose became dislodged and waste fluids came in contact with the operator while using their lh780 analytical station.The customer stated that a hose that carried biological waste from the instrument to the waste container became dislodged during sample processing.A spill occurred that came in contact with the operator's skin and eyes.The customer was wearing a lab coat and gloves with no face protection.The operator was seen by a doctor and was found to be in good health but was prescribed retroviral medication as a preventive measure.No further treatment requirement was reported.There were no erroneous results generated as a result of this event.There was no effect to patient treatment.The instrument was installed on (b)(6) 2018, the event occurred in (b)(6) 2019 during its first use.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 8445070
• MDR Text Key: 139599350
• Report Number: 1061932-2019-01376
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)161007
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K061616
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/01/2019
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other