MAUDE Adverse Event Report: INTEGRA ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM

Model Number INS8400

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It is suspected / probable that there is a bad lot of evd's in the hospital's possession.Pt in nsi bed 8 was having issues with their evd the past 24-36 hours - issues included: icps jumping all over the place, nurses would drop the system to the floor and evd would drain fine and then when they would put it back to where it needed to be at eam, it would appear to suck air back into the head from the chamber.Per physician, "when it would rise above the head, it would fill with air in the chamber like a monometer and would oscillate at the pt's icp" (much like when doing a lumbar puncture).Physicians were stumped as to why this was happening.Accudrains were closely inspected with no noted cracks or breaks in the system.The entire system was changed out per rn on day shift and the same problems ensued.Dr on sunday night and wondered if it was a bad lot of evds.He had our tech go down to operating room and get a new accudrain from their pyxis.Sure enough, when the system was changed out with the accudrain from the operating room, all problems ceased and there have been no issues since.Further investigation showed that all previous accudrains that were in the pt's head that caused these issues were from the same lot, which is #1170009.After further investigation from speaking with dr and the nurse taking care of the pt, all stopcocks were open during this time and were set correctly (except for the yellow stopcock that collected fluid in the chamber as per protocol as this is only opened once per hour).Dr hypothesized that possibly it was some one way valve that seemed to not be functioning correctly.On the night of the discovery, rn taking care of pt and charge nurse found two add'l accudrains with this lot number in our pyxis, so i took them out and put them on my unit director's desk.The other drains that were not functioning correctly got placed in a red bag in nio's office.All charge nurses, unit director and neuroscience educator were emailed about the incident as soon as it was discovered for f/u.

• Brand Name: ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
• Type of Device: ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
• Manufacturer (Section D): INTEGRA; plainsboro NJ
• MDR Report Key: 6659568
• MDR Text Key: 78293860
• Report Number: MW5070545
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2018
• Device Model Number: INS8400
• Device Lot Number: 1170009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1