MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 20 ML

Catalog Number INS9020

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Device Inoperable (1663)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Type  Injury  

Event Description

This is the first of three reports (same product id, same patient, similar problem).This is in regards to the limitorr#1.Linked to mfg report numbers:2648988-2014-00068 and 2648988-2014-00069.The female patient had the limitorr(#1) on and the nurse found the stopcock had failed.The tubing fell apart and the patient overdrained cerebrospinal fluid (csf).They put another limitorr(#2) on and that one too failed a short time later (time unknown).A third limitorr (#3) was opened and while setting up, the tubing came out of the stopcock.Limitorr #3 was never attached to the patient.The patient had to have a new drain (becker) put in.It was reported that the patient had headache and leg/foot pain due to the overdrainage.Additional was requested and on 03dec2014 and 04dec2014, the following was provided by the customer: the (b)(6) female with an underlying condition of subarachnoid hemorrhage had limitorr placement to drain csf from the lumbar spine.Limitorr#1: the customer was just told that limitorr#1 leaked and it was replaced with limitorr #2.The customer was not told or given any details surrounding limitorr#1, including when it was originally placed.Limitorr #1 is not available for evaluation.Limitorr #2: limitorr #2 was first placed/used on patient on (b)(6) 2014 at 2200.Limitorr #2 failed on (b)(6) 2014 at 1315, leaked at the stopcock.With regards to how frequent the patient line stopcock was manipulated and for what process, the customer reported that the patient was on bed rest so the stopcock was not manipulated.The patient was being turned in bed every 2 hours per hospital policy.It was reported that most patients with this injury do receive daily "ct's".It was unknown how much csf overdrainage was due to the limitorr #2 although hourly csf drainage were recorded in charting up until 1400.As far as the customer knows, the patient did not experience any leg/foot pain.The patient however experienced hypertension, systolic blood pressure (sbp) >220, headache (ha) and ectopy on cardiac monitor.The drain was replaced using sterile technique.The patient was medicated for comfort and broad spectrum antibiotics was started on the patient.Limitorr #2 has been sent back for evaluation.Limitorr#3: date limitorr #3 was opened/tried to be used on (b)(6) 2014 at 1345.However, it was never placed in the patient.This drain was taken out of the packaging by the medical doctor (md) and inspected.It had come apart at the seam/connection point in the tubing.After further discussion with the md, they did put tension by pulling the tubing to see if it would take much force to make it come apart.According to the md's, little pulling force was utilized to make it come apart.This limitorr#3 has been sent back for evaluation.Since limitorr#2 needed to be replaced and limitorr#3 fell apart, a competitor drainage (becker) was used instead.Patient outcome was reported as "patient is doing well".

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: LIMITORR VOLUME LIMITING EVD 20 ML
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4337984
• MDR Text Key: 20327916
• Report Number: 2648988-2014-00067
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS9020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR