• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number 723585
Device Problems Leak/Splash (1354); Output Problem (3005)
Patient Problem Not Applicable (3189)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) evaluated the instrument.The fse found the needle bellows check valves were clogged.The fse replaced the check valves to resolve the leak and the aspiration errors.The fse also found that pumps pm2 and pm3 were generating air bubbles.The fse replaced pumps pm2 and pm3 to resolve the issue.The repairs were verified by the fse.The beckman coulter internal identifier for this event is (b)(4).
 
Event Description
While troubleshooting a leak inside the coulter lh 780 hematology analyzer the field service engineer (fse) found the diluent dispensers were generating bubbles.The instrument was generating aspiration errors at the time of the event.The volume of the leak was about 3 ml and was not contained within the instrument.The customer was wearing personal protective equipment (ppe) consisting of 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 affect to patient treatment in connection with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COULTER LH 780 HEMATOLOGY ANALYZER
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECKMAN COULTER
250 south kraemer blvd.
brea CA 92821
Manufacturer (Section G)
BECKMAN COULTER
11800 sw 147th ave
miami FL 33196
Manufacturer Contact
miranda holland
11800 sw 147th ave
32-s08
miami, FL 33196
3053802031
MDR Report Key6043957
MDR Text Key57983918
Report Number1061932-2016-00913
Device Sequence Number1
Product Code GKZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061616
Number of Events Reported1
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 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number723585
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-