MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605632

Device Problems Bent (1059); Failure to Align (2522); Device Displays Incorrect Message (2591)

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

Event Date 06/17/2014

Event Type  malfunction  

Event Description

The customer reported the needle on the bellows assembly of a coulter lh 750 hematology analyzer was bending and was not properly aligned with the sample tubes.In addition, the instrument had generated an error message concerning the bellows.While visually inspecting the instrument, the operator was sprayed over the gown area with an unknown amount of bloody fluid; this occurred during the instrument's backwash cycle.There was no contact with the facial area or exposure of the leak to mucous membranes or open wounds.The operator was wearing gloves, eye protection, and a lab coat.There were no erroneous patient results generated in connection with this event.There was no death, injury, or change to patient treatment attributed to this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse could not reproduce the leak, but replaced the needle assembly and verified alignment.To ensure proper piercing, the fse adjusted the stripper plate and needle bellows air cylinder, which resolved the errors produced by the instrument.Service activity was verified to meet the specified requirements per established procedures.(b)(4).

• Brand Name: COULTER LH 750 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: 3929348
• MDR Text Key: 16541181
• Report Number: 1061932-2014-01597
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605632
• Other Device ID Number: SW VERSION 3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2003
• 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