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

Catalog Number 723585

Device Problems Display or Visual Feedback Problem (1184); Fluid/Blood Leak (1250); Retraction Problem (1536)

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

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on (b)(4) 2015 and found the spring in the blood sampling valve (bsv) knob was worn and would not hold in place to secure the bsv.The leak was a clear fluid from between the bsv pads.The fse ordered a replacement bsv knob and returned the following day and replaced two kinked tubes at the bsv along with bsv knob to resolve the leak and movement issues at the bsv.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer reported that there was an uncontained clear fluid leak of an unknown volume from a coulter lh 780 hematology analyzer.The customer also reported voteouts (non-numeric results) on white blood cells (wbc), red blood cells (rbc), platelets (plt) and mean cospuscular volume (mcv) parameters and that the manual probe would not retract.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat, goggles and gloves at the time of the event and 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-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 4922886
• MDR Text Key: 22455980
• Report Number: 1061932-2015-01167
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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