MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET EDMS, SMARTSITE; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Catalog Number 46914

Device Problems Disconnection (1171); No Device Output (1435)

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

Event Date 10/20/2014

Event Type  malfunction  

Event Description

It was reported to medtronic neurosurgery that the device was used on the patient following a lumbar drain procedure.According to the report, on (b)(6) 2014, in the afternoon, the staff nurse on duty noticed that there was no csf collected in the chamber.Reportedly, at around 6:60 pm it was found that there still wasn¿t any csf collected.According to the report, it was noticed that there was yellowish fluid on the floor just below the duet system and it was discovered that there was a disconnection between the drip chamber and the 3-way stopcock.The report stated that there was no injury to the patient and that the patient is in a stable condition.

Manufacturer Narrative

The device was patent.The stopcock below the drip chamber was disconnected from the drip chamber.The damage led to the device not meeting the requirements for the leakage test.There was adhesive noted at the connection.The drainage bag was stuck to the connector and could not be unscrewed.Application of excessive force in the tightening or loosening of the drainage bag connection may have led to the damage.The instructions for use (ifu) that accompanies the device caution that ¿in order to avoid possible cracking of the luer connectors after cleaning with alcohol, or a disinfectant containing alcohol allow to air dry completely prior to connecting the system¿.Also, the ifu cautions that ¿all connections should be finger tightened.Over tightening can cause cracks and leaks to occur¿.A review of the manufacturing records showed no anomalies.(b)(4).

• Brand Name: DUET EDMS, SMARTSITE
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 4263587
• MDR Text Key: 5110399
• Report Number: 2021898-2014-00452
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K983799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2014

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: 46914
• Device Lot Number: 208254919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 00062 YR
• Patient Weight: 45