MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 178833

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

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

Event Date 08/08/2014

Event Type  malfunction  

Event Description

The customer reported the coulter lh 500 hematology analyzer generated ambient and lyse temperature errors.There was no exposure to open wounds or mucous membranes.No erroneous results were generated in connection with the reported event.There was no death, injury, change to patient treatment attributed to this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.The fse confirmed a leak from a hole in the black tubing through pinch valve (pv37).The leak consisted of approximately 20 mls of clenz that leaked from the analyzer onto the counter.The leak was not contained within the instrument.The fse replaced the tubing through pinch valve (pv37), resolving the leak.The leak had damaged the peltier circuit board and associated connector (p4).The fse replaced the peltier board and connector, resolving the ambient lyse and temperature errors.While onsite, the fse replaced the tubing on the center module, pump module, differential module, level sense module, and complete blood count (cbc) module as part of preventative measure.The fse verified the instrument and the instrument was returned to normal operation.The operator/fse was wearing the personal protective equipment (ppe) consisting of gloves, masks/protective eyewear and a lab coat at the time of the incident.(b)(4).

• Brand Name: COULTER LH 500 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: 4052738
• MDR Text Key: 21729719
• Report Number: 1061932-2014-02152
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• 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: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2010
• 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