FDA Adverse Event Malfunction Summary report: N

GENESIS FE 500

MDR report key: 3953489 · Received June 12, 2014

Report

Report Number: 3003402518-2014-00004
Event Type: Malfunction
Date Received: June 12, 2014
Date of Event: May 14, 2014
Report Date: June 11, 2014
Manufacturer: TECAN SCHWEIZ
Product Code: JQW
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
347881	GENESIS FE 500	PIPETTING STATION FOR CLINICAL USE	JQW	TECAN SCHWEIZ

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other