LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM INS9020SP1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM INS9020SP1 manufactured by Integra Lifesciences Corporation.

Event Text Entries

[182429795] I was adjusting the external ventricular drain (evd) from 5 cm h2o to 10 cm h2o and the transducer connection felt off. Preparing pt for transport, transporter slightly nudged transducer, transducer broke off. The external ventricular drain evd device snapped at this connection point between where the transducer is placed. External ventricular drain evd was already in use for this pt and had to be emergently swapped out with a new drain system. At change of shift the oncoming night rn and day rn performed bedside report. At the end of report the day rn noticed that something appeared 'off' about the transducer portion of the patient's evd. Upon further inspection it was discovered that the plastic portion which connects the transducer to the evd had broken off. At that time, the site where the evd had broken was covered with a iodine pad to prevent the system from being open to the environment. The neurosurgical team was immediately paged regarding the incident. The team contacted the night rn to gather more information and inform the night rn to setup a new evd for connection. A photo of the broken equipment was taken and an email was submitted to the unit management team to notify them of the incident. The broken piece was placed inside a specimen bag for further evaluation if desired. A new evd was setup and the neurosurgical resident came to the bedside to connect the new evd to the patient. After connection, patency was confirmed and a intracranial pressure (icp) waveform was checked. Returned from transferring another patient off unit, patient external ventricular drain evd noted to be broken at transducer. Evd clamped and transducer placed inside of sterile dressing. Neurosurgery paged, evd set up replaced. Day rn at bedside to perform handoff. When rn went to zero evd, transducer loose and became disconnected from drain tubing. Sterile gauze placed around evd and drain clamped. Picu fellow called to bedside and neurosurgery contacted. Neurosurgery performed new drain set up and faulty drain set aside for evaluation. Patient remained stable throughout process. Evd broke near transducer causing cerebrospinal fluid to leak. Whole system had to be replaced. I was moving the monitor and my back side bumped the patient evd. The evd was broken where the transducer joins the drain. The evd needed to be replaced. Evd discovered to be leaking bloody cerebrospinal fluid on the floor. On close examination the transducer had sheared off at the manifold. Ns md contacted and drainage set changed out by md. Patient neurologically unchanged. When moving pt up from bed, evd transducer hit the side of the alaris pump causing the evd transducer to snap apart where it attaches to evd setup. Evd was clamped off to pt. Neurosurgery was notified and summoned to bedside to reconnect evd setup. Md from neuro surg reconnected new evd set up. Parents were also made aware and had no additional concerns. No adverse sequela occurred from this event. Pt continues to be a neurological baseline post-event as they were prior to while changing the drainage bag and manipulating the drain set the transducer section broke off. Went into room to check evd and found transducer hanging off of evd with csf leaking out. The plastic was broken at the connection. Drain was turned off to patient and nsg was called to bedside to replace system. External ventricular drain evd plastic broke at transducer/tubing site. External ventricular drain evd remained clamped and neurovascular team was notified to change out external ventricular drain evd tubing external ventricular drain evd transducer broke off at connection site near stopcock. External ventricular drain evd transducer broke, clamped to patient, new external ventricular drain evd set up and attached by md. Patient was carefully transferred to radiation treatment table. Rn was closely monitoring external ventricular drain evd and transducer as patient was being secured on table for radiation treatment. However, while being secured in, transducer still broke off limitorr port. External ventricular drain evd was clamped, and broken transducer port was wrapped with sterile gauze. Md with neurosurgery notified and replaced new limitorr set up. Pts vss, and exam unchanged. When arrived to [department] from transport from icu, saw external ventricular drain evd transducer looked "crooked" so decided to try to fix it and the external ventricular drain evd transducer had snapped off completely. Dr was notified about the external ventricular drain evd system needing to be replaced. I set a new drainage system up and let him know we were in [department] so he can attach the new system. Per dr, external ventricular drain evd was to be clamped for the procedure. A nursing order was placed for the clamp. The new drainage system was then attached by dr as soon as the patient arrived from [department]. Transducer connection broke off. External ventricular drain evd was clamped at the time. Neurosurgery was at the bedside at the time and informed. External ventricular drain evd setup was not able to be used. Pt's external ventricular drain evd system had transducer break clean off site. At start of shift transducer looked slightly loose on system but later in shift broke clean off without being touched. External ventricular drain evd clamped. Team came to bedside to exchange system. External ventricular drain evd transducer found to be broken at connection site, no obvious cause noted at the time. Neurosurgical resident dr. Notified to change new external ventricular drain evd setup. At some point, while patient was being transferred from icu bed to or table, transducer was broken off of external ventricular drain evd. The break was where the transducer arm connects to main body of external ventricular drain evd.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9801117
MDR Report Key9801117
Date Received2020-03-06
Date of Report2020-03-05
Date of Event2019-04-29
Report Date2020-03-05
Date Reported to FDA2020-03-05
Date Reported to Mfgr2020-03-06
Date Added to Maude2020-03-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Generic NameVOLUME LIMITING CSF DRAINAGE SYSTEM
Product CodeJXG
Date Received2020-03-06
Model NumberINS9020SP1
Catalog NumberINS9020SP1
Device AvailabilityN
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION
Manufacturer Address1100 CAMPUS ROAD PRINCETON NJ 08540 US 08540


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.