IMMUCOR/GAMMA CSW 100 6510/8441-10 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-25 for IMMUCOR/GAMMA CSW 100 6510/8441-10 * manufactured by Tricontinent.

Event Text Entries

[592449] 1. Biohazardous waste was aerosolized from the waste container. 2. Unit puts waste into the waste container with the waste sensor unplugged. The immucor/gamma rep was on site to train laboratory personnel on the capture system. She was demonstrating the waste bottle sensor features. The waste bottle was almost full -as described in section 2. 6 page 6 of the operation and maintenance manual-. A full tray of wells was loaded to wash. Start was pressed. The system began washing the strips. After washing a number of strips, biohazardous waste began spewing out the top of the waste bottle. The system continued to wash. User had to press the "stop" button before the system would stop aerosolizing biohazardous waste from the top of the waste bottle. With the waste sensor unplugged or malfunctioning -waste bottle level is not known- the system will prime and rinse the probes causing waste to go into a waste bottle that may already be full.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1042345
• MDR Report Key: 832733
• Date Received: 2007-03-25
• Date of Report: 2007-03-25
• Date of Event: 2007-02-23
• Date Added to Maude: 2007-04-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: IMMUCOR/GAMMA CSW 100
• Generic Name: CAPTURE STRIP WELL WASHER
• Product Code: FLH
• Date Received: 2007-03-25
• Model Number: 6510/8441-10
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 820052
• Manufacturer: TRICONTINENT
• Manufacturer Address: 12555 LOMA RICA DR GRASS VALLEY CA 95945 US

Device Sequence Number: 2

• Brand Name: GAMMA CSW 100
• Generic Name: CAPTURE STRIP WELL WASHER
• Product Code: FLH
• Date Received: 2007-03-25
• Model Number: 8441-10
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 820163
• Manufacturer: TRICONTINENT
• Manufacturer Address: 12555 LOMA RICA DR GRASS VALLEY CA 95945 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-03-25