MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED LICOX; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Lot Number 0213478

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Code Available (3191)

Event Date 10/06/2019

Event Type  malfunction  

Event Description

After completing pt bath, 10 mg propofol bolus given prior to repositioning.2 rn began repositioning pt onto right side when pt began violently coughing and thrashing upper body and head back and forth.Additional 50 mcg fentanyl bolus given.Rn observed blood tinged csf pouring onto bed as pt continued coughing.Both rn immediately positioned pt onto back and raised hob to 45 degrees.While assessing pt, fiberoptic piece from licox/camino bolt dislodged and fell onto pt's bed.Blood tinged csf expelled out of bolt device.One rn held gloved hand over site to stop csf while another rn ran to grab cap to stop csf pouring out.Writer rn stayed at bedside holding pt in place to immobilize.Sterile blue cap placed over opening of bolt.Paged neurosurgery resident on call immediately during event to assess pt and licox/camino.Neurosurgery physician returned page and promptly at bedside.Per neurosurgery physician, keep sterile blue cap screwed onto bolt piece until further evaluation in am as well as leave evd unclamped when repositioning pt.Continuous leaking around bolt site, neurosurgery resident at bedside to assess, bolt removed after consulting neurosurgery team.

• Brand Name: LICOX
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 9544030
• MDR Text Key: 173501871
• Report Number: 9544030
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0213478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9855 DA