MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number N/A

Device Problems Fire (1245); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2017 the field service engineer (fse) replaced the sample aspiration module (sam) module resource controller (mrc) to resolve the blood sampling valve (bsv) mechanical drive communication issue; per phone communication with the fse on (b)(4) 2017, this is when the spark and flame was observed coming from the sam mrc board.The fse replaced the affected sam mrc board resolving the issue.Per beckman coulter product compliance engineer, there is no electrical hazard present on an mrc board.The boards operates at 24 vdc, which is considered a non-hazardous voltage per safety standard iec 61010-1 and is considered self-extinguishable.With regards to the spark and small flame seen on the instrument, this event is not classified as a fire event, at best this event is considered a momentary event caused either by a low voltage component failure, or by the inadvertent shorting of the board during troubleshooting.In an abundance of caution, bec has filed the report for this event based on the reported visible flame.Bec internal identifier - (b)(6).

Event Description

The field service engineer (fse) reported observing a clear spark then a small flame with smoke after the installing the sample aspiration module (sam) module resource controller (mrc) board while troubleshooting blood sampling valve (bsv) move errors on the dxh 800 instrument.Per the fse the magnitude of the flame was very small and contained within the instrument.A fire extinguisher was not needed and the instrument was immediately powered off.The lab was not evacuated.There was no reported injury and no medical attention was required by the operator.Erroneous results were not generated and there was no change or affect to patient treatment in connection with this event.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• 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 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue,; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7144005
• MDR Text Key: 95695089
• Report Number: 1061932-2017-00022
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2017

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: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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