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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Not Applicable (3189)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

On 12/08/2015 the field service engineer (fse) found a pinhole on pinch valve pv3 that caused the leak and no counts.The replaced the tubing and the instrument ran without leaks and started generating counts.The repairs were verified per established procedures.The beckman coulter internal identifier for this event is (b)(6).

Event Description

The customer reported a contained clear leak of less than 1 ml from pinch valve pv3 inside the coulter hmx analyzer while running samples.The customer reported that no wbc (white blood cell) counts were being generated.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 and gloves 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 HMX 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 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 5332951
• MDR Text Key: 34647728
• Report Number: 1061932-2015-01808
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010765
• 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
• Type of Report: Initial
• Report Date: 12/07/2015

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6605526
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• 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