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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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INTEGRA LIFESCIENCES CORPORATION ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number INS8400
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 07/20/2021
Event Type  malfunction  
Event Description
While walking pt to the restroom, rn heard something fall to the floor. Rn got pt to toilet, then went back to look at what had fallen. Rn saw evd transducer on floor, with a trail of fluid to the toilet (csf). Rn immediately ran to evd and clamped port off from which transducer fell from and was actively draining pt¿s csf onto floor. Neurosurgery notified. Port remained clean/uncontaminated, was appropriately cleaned and new transducer replaced. Spoke with rn who filed the event report. She states this transducer disconnected again today when ambulating to the br. These fairly new evd set ups are attached to a fixed point on an iv pole. When a patient is up and walking, the transducer cord has to be disconnected, which leaves the approximately 12 inch cord from the transducer swinging loose. This may produce enough torque to loosen and eventually disconnect the transducer form the buretrol. Will consult with the nicu educator to possibly add some extra teaching for this issue.
 
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Brand NameACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
1100 campus rd
princeton NJ 08540
MDR Report Key12364873
MDR Text Key268046585
Report Number12364873
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberINS8400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2021
Event Location Hospital
Date Report to Manufacturer08/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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