MAUDE Adverse Event Report: M DIALYSIS INC., AB ISCUS FLEX MICRODIALYSIS ANALYZER; GENERAL PURPOSE REAGENT

Model Number 614565

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Information (3190)

Event Date 06/27/2018

Event Type  Injury  

Event Description

Both of our cerebral microdialysis, (cmd) analyzers were rendered inoperable, no results could be obtained for this pt on (b)(6) 2018.From 2015 to 2017, one or both of our cmd analyzers were down 22% of the time, with prolonged downtime intervals.This analyzer platform is unfit for clinical use.Dates of use: 2014, (b)(6) 2018.Diagnosis or reason for use: cerebral trauma monitoring.The ordering clinicians were notified that these results would not be available.Lab leadership has notified the vendor as of (b)(6) 2018 of the intent to discontinue this testing due to persistent, and ongoing analyzer platform instability.An unstable platform such as the cmd analyzer, when coupled with the inappropriately prolonged intervals to scheduling field service engineer arrivals for repairs (often greater than one week) renders the cmd analyzer device completely unsafe for its intended clinical use in cerebral monitoring for pts at risk with acute traumatic brain injuries.Field svc engineer for the cmd analyzers could not be scheduled in a reasonable time frame to enable safe clinical application of this product to our pts.These implanted brain catheters are connected to a pump, and the fluids removed from pts' brains are sent to the lab in special microvials for analysis on the cmd analyzer.

• Brand Name: ISCUS FLEX MICRODIALYSIS ANALYZER
• Type of Device: GENERAL PURPOSE REAGENT
• Manufacturer (Section D): M DIALYSIS INC., AB; north chelmsford MA
• MDR Report Key: 7784286
• MDR Text Key: 117325636
• Report Number: MW5079142
• Device Sequence Number: 2
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 614565
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2018
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR