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

Catalog Number 723585

Device Problems Break (1069); Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

The customer reported a leak, and loose tubing and a broken assembly below the probe wipe of the coulter lh 780 hematology analyzer.The leak was described as bluish reagent, approximately 5 ml in volume and contained within the analyzer.The customer indicated that the leak did not appear to affect sample or reagent integrity, and there was no evidence of cross-contamination.The system was stopped to avoid impact on electrical or optical performance of the instrument.The instrument did not generate an error message.There were no erroneous results either generated or reported.Samples were repeated on a backup analyzer and the results appear to correlate.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the analyzer.The operator was wearing a lab coat and gloves at the time of the incident.There was no report of biohazard exposure to mucous membranes or open wounds.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 replaced the probe wipe rinse block and worn tubing through pinch valve vl12b to resolve the reported issues.The fse verified and validated the system.(b)(4).

• 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
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4194707
• MDR Text Key: 20017856
• Report Number: 1061932-2014-02674
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Other Device ID Number: SOFTWARE VERSION: 1B3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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