MAUDE Adverse Event Report: CARDINAL HEALTH CANISTER FLEX 1500CC W/STRAIGH; SUCTION CANISTER

Model Number 65652-618

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

Patient Problems Cardiopulmonary Arrest (1765); Fall (1848)

Event Date 02/03/2014

Event Type  Injury  

Event Description

An incident occurred in a ward where a wall mounted suction unit failed during an emergency suctioning on a collapsed patient.The patient was found on the floor at the doorway of the ward side-room and the suction tubing was not long enough to reach the patient, so the canister was taken off the wall.Initially the suction was heard for a second, then went quiet.The suction was turned on and off at the wall several times, but suction could not be re-established.The ward's portable suction unit was used instead.The wall mounted suction canister was probably not in the vertical position when it was taken off the wall.The patient was resuscitated on the ward, but there was no injury.

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.Unfortunately the actual sample was not provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.However, pictures were received from the customer for evaluation.The pictures depicted one flex advantage disposable liner and an outside polycarbonate canister.The polycarbonate canister had a date code of (b)(6) 2003.We were unable to determine the date of manufacture of the flexible liner from the pictures received.No lot number was provided by the customer; therefore, a review of the manufacturing device history record could not be performed.Based on the information provided, no specific assignable root cause can be determined.Without a specific assignable cause, no specific corrective action can be taken.Per our instructions for use, premature shut off of the vacuum may occur under the following conditions for the mechanical shut off system.The canister is bumped or moved suddenly from a vertical position.The shut off valve is angle sensitive and designed to stop the vacuum under these conditions.Allow for enough patient tubing during use to avoid tilting the canister when the tubing is pulled and moved during a procedure.Further correspondence from the customer indicated that the suction was found to be intermittent.The sales representative who was in contact with the hospital organized the replacement of all polycarbonate canisters and has indicated there is no more issues.We will continue to monitor concerns such as these for possible future actions.

• Brand Name: CANISTER FLEX 1500CC W/STRAIGH
• Type of Device: SUCTION CANISTER
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 3815776
• MDR Text Key: 15809992
• Report Number: 1423537-2014-00018
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 65652-618
• Device Catalogue Number: 65652-618
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR