MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEVELERT II FLUID LEVEL SENSOR; MONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS

Catalog Number 7211011

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the levelert ii fluid level sensor doesn't alarm when the fluid bag is at the desired alarm level.No backup device available.Procedure completed without a fluid management device.No patient injury or complications were reported.

Manufacturer Narrative

Complaint of alarm malfunction could not be confirmed.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.Product passed functional testing and alarm function performed as expected.No containment or corrective actions are recommended at this time.No problem found.

• Brand Name: LEVELERT II FLUID LEVEL SENSOR
• Type of Device: MONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6255700
• MDR Text Key: 65354083
• Report Number: 1643264-2017-00038
• Device Sequence Number: 1
• Product Code: FLN
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K060123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7211011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1