MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for ISCUS FLEX MICRODIALYSIS ANALYZER 641564 manufactured by M Dialysis Inc., Ab.
[117325636]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079142 |
| MDR Report Key | 7784286 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-06-27 |
| Date Added to Maude | 2018-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ISCUS FLEX MICRODIALYSIS ANALYZER |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | PPM |
| Date Received | 2018-08-14 |
| Model Number | 641564 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M DIALYSIS INC., AB |
| Manufacturer Address | NORTH CHELMSFORD MA US |
| Brand Name | ISCUS FLEX MICRODIALYSIS ANALYZER |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | PPM |
| Date Received | 2018-08-14 |
| Model Number | 614565 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | M DIALYSIS INC., AB |
| Manufacturer Address | NORTH CHELMSFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-14 |