SLIDEPREP PLUS CYTOLOGY CENTRIFUGE 100-400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-16 for SLIDEPREP PLUS CYTOLOGY CENTRIFUGE 100-400 manufactured by Separation Technology, Inc. Part Of Thermo Fisher Scientific.

Event Text Entries

[2931460] Customer reported that the lid of the slideprep plus cytology centrifuge was open and the operator was putting slides into it when the rotor began to spin on its own. The operator noticed the rotor beginning to spin and pulled his hand away before any injuries occurred. The customer returned the device to separation technology, inc on (b)(6) 2012 under rga 34447. Initial attempts to duplicate the failure were unsuccessful. Customer contacted on (b)(6) 2012, for more details regarding the incident to help with duplicating the failure. Customer responded with an e-mail on (b)(6) 2012, that provided little additional detail regarding the incident other than to say that the rotor did not stop turning when the stop button was pressed, so the power switch was turned to off to stop the rotor. Additional attempts to cause the rotor to turn with the lid open were not successful. On (b)(6) 2012, the device was opened to inspect the inside. The motor ground wire, which is the most likely cause of this failure, was tight. No obvious causes to the failure could be found. A jumper wire was found to be pinched, but with no metal wire exposed through the insulation. A continuity test of the wire revealed no adverse effect of the pinching. On (b)(6) 2012, further inspections were conducted by an electrical engineer. No abnormalities could be found inside the device. The engineer tried wiggling and vibrating key components of the device to trigger the rotor motor, with no success. The engineer closed the device and began operating it at various speeds, and tried loading and unloading the rotor to trigger the motor to start, also with no success. As of (b)(6) 2012, testing had still not been able to duplicate the failure. Testing shall continue and a follow-up report shall be completed once all possible causes are investigated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721649-2012-00001
• MDR Report Key: 2711026
• Report Source: 06
• Date Received: 2012-08-16
• Date of Report: 2012-08-15
• Date of Event: 2012-07-20
• Date Mfgr Received: 2012-07-20
• Device Manufacturer Date: 2011-09-30
• Date Added to Maude: 2012-12-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: STACEY HERRON
• Manufacturer Street: 582 MONROE ROAD SUITE 1424
• Manufacturer City: SANFORD FL 32771
• Manufacturer Country: US
• Manufacturer Postal: 32771
• Manufacturer Phone: 4077888791
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SLIDEPREP PLUS CYTOLOGY CENTRIFUGE
• Generic Name: SLIDEPREP PLUS
• Product Code: IFB
• Date Received: 2012-08-16
• Returned To Mfg: 2012-07-31
• Model Number: 100-400
• Catalog Number: 100-400
• Lot Number: 033
• Operator: OTHER
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SEPARATION TECHNOLOGY, INC. PART OF THERMO FISHER SCIENTIFIC
• Manufacturer Address: SANFORD FL US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-08-16