MAUDE Adverse Event Report: MOELLER MEDICAL GMBH & CO. KG LIQUOGARD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number LIQUOGARD

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 10/01/2014

Event Type  No Answer Provided  

Event Description

Day 1: liquogard csf drainage system alarmed for low pressure.Nurse noted central spinal fluid had leaked out through a crack in the system's tubing set where it connects with the sensor.The tubing was replaced resolving the issue.Day 3: tubing set broke again on the same patient.Use of the csf drainage system was then discontinued.

• Brand Name: LIQUOGARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MOELLER MEDICAL GMBH & CO. KG; 1612 jenks drive; corona CA 92880
• MDR Report Key: 4253114
• MDR Text Key: 20780987
• Report Number: 4253114
• Device Sequence Number: 2
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/24/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Device Model Number: LIQUOGARD
• Device Catalogue Number: 00003640
• Device Lot Number: A0Q361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2014
• Patient Sequence Number: 1
• Patient Age: 13 MO
• Patient Weight: 7