MAUDE Adverse Event Report: BECKMAN COULTER OPTIMA XE-90 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number B10044

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

The customer reported that the optima xe-90 centrifuge produced a "d509" diagnostic code for temperature diagnostic and open or short circuit in the thermoelectric module circuit.The customer also reported that there was no refrigeration with the centrifuge.There was no report of smoke, fire, burning smell or injury associated with this event.Patient results were not affected and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer's site.The fse evaluated the centrifuge and discovered that the heatsink was burned.The fse replaced the heatsink assembly to resolve the issue and verified the repair as per established procedures.The optima xe-90 centrifuge is compliant with the european safety standards en61010: safety requirements for electrical equipment for measurement, control and laboratory use.A failed heatsink assembly is contained inside of an enclosure with no risk to the spread of fire.(b)(4).

• Brand Name: OPTIMA XE-90 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 5355 w. 76th street; indianapolis IN 46268
• Manufacturer Contact: dung nguyen ; 250 s. kraemer boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 4137085
• MDR Text Key: 18929909
• Report Number: 3007448124-2014-00005
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: CLASS I EXEM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B10044
• Other Device ID Number: SW VERSION 1.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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