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

Catalog Number 723585

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 10/07/2016 and found a leak from check valve (cv 8) letting clenz bubbles out of the white blood cell (wbc) bath.The fse replaced the check bath resolving the leak.The fse also replaced pinch valve (vl10) which was loose and broken but did not malfunction and the aperture o-rings as a preventative measure.The instrument ran without leaks and all repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported a leak of blood-diluent and cbc lyse fluid of approximately < 1.0 ml in volume which was contained within the coulter lh 780 hematology analyzer.The customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves at the time of the event.There was no report of injury or biohazard exposure to open wounds or mucous membranes.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.

• 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: miranda holland ; 11800 sw 147th avenue; 32-l23; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 6061786
• MDR Text Key: 58609209
• Report Number: 1061932-2016-00921
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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