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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER

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BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER Back to Search Results
Catalog Number 723585
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2015
Event Type  malfunction  
Manufacturer Narrative
The field service engineer (fse) was onsite on 12/03/2015 and found that the tubing had popped off the blood sampling valve (bsv) at fitting 10.The fse replaced tubing from bsv to fitting 10.The instrument was verified to meet the specified requirements per established facility procedure.(b)(4).
 
Event Description
The customer reported approximately 2 l of an uncontained greenish blue fluid leaked from the coulter lh 780 hematology analyzer onto the floor while cycling patient samples.There were no error messages reported by the customer at the time of the event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results or controls.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat and gloves at the time of the event and there was/no report of injury or biohazard exposure to open wounds or mucous membranes.
 
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Brand Name
COULTER LH 780 HEMATOLOGY ANALYZER
Type of Device
COULTER LH 780 HEMATOLOGY ANALYZER
Manufacturer (Section D)
BECKMAN COULTER
250 s. kraemer blvd
brea CA 92821
Manufacturer (Section G)
BECKMAN COULTER, INC.
11800 sw 147th avenue
miami FL 33196 2031
Manufacturer Contact
miranda holland
11800 sw 147th avenue, 32-s08
miami, FL 33196-2031
3053802031
MDR Report Key5325015
MDR Text Key34303671
Report Number1061932-2015-01873
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 12/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number723585
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2015
Initial Date FDA Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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