MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC GUARDIAN CANISTER; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number 65651-100

Device Problem Suction Problem (2170)

Patient Problem No Code Available (3191)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

This is the second occurrence of this equipment failure.The suction canister has a float valve stopper that is to stop the flow of suction when the canister becomes full.This action prevents any fluid from being sucked up into the suction lines in the wall suction unit.While doing an infected knee, the canister continued to suck after filling, sending an undetermined amount of irrigated fluid into the wall attachment.

• Brand Name: GUARDIAN CANISTER
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1430 waukegan rd-mpkb-2b; mcgaw park IL 60085
• MDR Report Key: 3801873
• MDR Text Key: 4526674
• Report Number: 3801873
• Device Sequence Number: 1
• Product Code: GCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 65651-100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2014
• Patient Sequence Number: 1