MAUDE Adverse Event Report: TECAN SCHWEIZ GENESIS FE 500; PIPETTING STATION FOR CLINICAL USE

Catalog Number 10352630

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 05/14/2014

Event Type  malfunction  

Event Description

The instrument genesis fe 500 includes a centrifuge (rotanda 46 rsc robotic; catalog #4816-71; manufacturer: (b)(4)).A bucket of the centrifuge serial #(b)(4) broke during the run.Nothing came out of the centrifuge, however, the front panel of the centrifuge blew off.The front panel of the automatic work station in which the centrifuge was integrated was also detached and fell onto the floor right in front of the work station.Nobody was hit or hurt.There was no injuries to any laboratory staff.

Manufacturer Narrative

A tecan field service engineer (fse) went onsite and observed centrifuge damage.From observation it appears bucket hanger #3 separated at the pivot point during operation damaging all internal parts of the centrifuge drum area (buckets, rotor, rotor shaft, drum).No pieces were ejected from the containment of the unit; however, residual shock damage to the control and front panel is evident.Damage to the outer casing as well.The front panel of genesis fe 500 instrument did not sustain any damage, however, it was knocked off.Genesis fe 500 has no damage outside processing functions except centrifugation.Damaged centrifuge is being sent to the manufacturer ((b)(4)) for further investigation.

• Brand Name: GENESIS FE 500
• Type of Device: PIPETTING STATION FOR CLINICAL USE
• Manufacturer (Section D): TECAN SCHWEIZ; maennedorf, zuerich ; SZ
• Manufacturer Contact: seestrasse 103; maennedorf, zuerich 8708 ; 9228560
• MDR Report Key: 3953489
• MDR Text Key: 4628964
• Report Number: 3003402518-2014-00004
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10352630
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other