MAUDE Adverse Event Report: BECKMAN COULTER COULTER® LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

The customer indicated that pv65 was broken and a slow leak was also found coming from the piece of tubing from the back of the coulter lh 500 hematology analyzer.The leak was contained within the instrument.There was no biohazard exposure to mucous membranes or open wounds.No erroneous results were reported as a result of this event.

Manufacturer Narrative

The field service engineer found the broken pinch valve mount on pv65 (vacuum necessary for erythrolyse delivery to mixing chamber).He noticed the instrument had been leaking slightly what appeared to be clenz.He traced the leak to the rbc bath drain tubing on the back of the cbc module and replaced the tubing.Solenoid 27 (responsible for delivery of erythrolyse) had also stopped working as result of the leak dripping on the connector.The solenoid was replaced.Instrument was verified according to the checklist.(b)(4).

• Brand Name: COULTER® LH 500 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: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3623560
• MDR Text Key: 4132661
• Report Number: 1061932-2014-00358
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/21/2014

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: NOT APPLICABLE
• Device Catalogue Number: 178833
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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