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

Catalog Number 723585

Device Problems Fluid/Blood Leak (1250); High Test Results (2457)

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

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was onsite on (b)(4) 2015 and found that customer had replaced tubing at pinch valves (vl111 and vl13) prior to his arrival to site, addressing the instrument issues.The instrument was verified to meet the specified requirements per established facility procedure.(b)(4).

Event Description

The customer reported that there had been a fluid leak in the coulter lh 780 hematology analyzer and a mist was observed near the primary needle.The retic scatter results were also high.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.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.

Manufacturer Narrative

Device manufacturing date was inadvertently omitted from original submission.

• 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 Key: 5300010
• MDR Text Key: 34140859
• Report Number: 1061932-2015-01837
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• 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