MAUDE Adverse Event Report: BECKMAN COULTER ALLEGRA X-5 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number B30589

Device Problems Smoking (1585); Vibration (1674)

Patient Problem Bruise/Contusion (1754)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument.The fse found that he instrument was defective.The fse did not find the causer of the instrument vibrating and generating smoke.The fse replaced the instrument and shipped the damaged instrument to the supplier for further investigation.The supplier did not provide any more information regarding the root cause of the incident.The customer was diagnosed with a deep bruise in a bone on her hand.She was prescribed a brace and is expected to fully recover.(b)(4).

Event Description

The customer reported the allegra x-5 centrifuge was vibrating and emitted smoke.When the instrument was vibrating it struck the customers hand.No fire or burning smell was reported.The fire department was not called and the customer did not require a fire extinguisher.There was no death related to this event.The customer went to a physician to get their hand checked and was diagnosed with a deep bruise in a bone on her hand.She required a brace to recover from the injury.

• Brand Name: ALLEGRA X-5 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 5224366
• MDR Text Key: 31468250
• Report Number: 3007448124-2015-00010
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B30589
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Other