MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

On 10/11/2016 the field service engineer (fse) found a leak in the diff sample line tubing to the mix chamber.The fse replaced the diff sample line and mix chamber drain tubing to fix the leak and no diff results.The repairs were verified per established procedures.(b)(4).

Event Description

The customer reported an uncontained diluted blood leak from the coulter lh780 hematology analyzer.The instrument was not generating diff results 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 and controls.The customer was wearing personal protective equipment (ppe) consisting of laboratory coat at the time of the event and there was no report of injury or biohazard exposure to open wounds or mucous membranes.

• Brand Name: COULTER LH780 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 Key: 6081791
• MDR Text Key: 59348470
• Report Number: 1061932-2016-00891
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 723585
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2016
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1