MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605632

Device Problems Break (1069); Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Customer reported aspiration errors were obtained after performing a calibration when using the coulter lh 750 hematology analyzer.The customer identified the tubing was broken off the needle assembly which resulted in a leak of about 10 ml of green colored fluid onto the counter.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the analyzer.While correcting the issue associated with the leak, the fse identified the backwash function of the needle assembly was sluggish, and identified a clog in the solenoid 61, which was unrelated to the reported leak.The operator was wearing personal protective equipment of lab coat and gloves when the leak was identified.There was no report of exposure to mucous membranes or cuts.There was no impact to patient results, as patient samples were not tested on the analyzer.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the analyzer and removed solenoid 61, and found obstruction most consistent with diluent salts in solenoid 61.Cleared obstruction from solenoid 61, and reinstalled the solenoid.The fse retested solenoid 6, and it opened and closed as expected.Instrument performance was verified.(b)(4).

• Brand Name: COULTER LH 750 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
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4248472
• MDR Text Key: 5104720
• Report Number: 1061932-2014-02816
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Catalogue Number: 6605632
• Other Device ID Number: SOFTWARE VERSION: 2D3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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