MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND VARIOLOCK TUBING CLAMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-81-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the variolock tubing clamp.The incident occurred in (b)(6).This medwatch report is filed on behalf of (b)(4).The customer reported to a (b)(4) sales representative that the ball bearings that keep the gate in place fell out and the gate then came apart.The parts were requested and returned to (b)(4) for further investigation.The reported issue was confirmed during evaluation.Wear was identified at the groove responsible for holding the gate in place while opened.It was found out that the wear and shavings were caused by the bolt.This issue can be caused if the spring plungers stiffen over the time due to dirt and corrosion.However, no traces of rust found at the gates.As corrective action, a change order has already been implemented.

Event Description

(b)(4) received a report that the gate of the variolock tubing clamp that holds the tubing in place came apart during a procedure.There was no report of patient injury.

• Brand Name: VARIOLOCK TUBING CLAMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6343987
• MDR Text Key: 67931217
• Report Number: 9611109-2017-00071
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-81-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1