MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for LOGOS manufactured by Milestone Medical Technologies, Inc..
[48434846]
Patient Sequence No: 1, Text Type: N, H10
[48434847]
Annual preventative maintenance was performed, by the manufacturer, in late march 2016. Reagent valve seals were replaced but not tightened to manufacturer specifications. Over a period of three weeks, the reagent valve seals loosened during the normal operating runs. The loosening of the valve seals prevented reagents from completely returning to their original supply containers. This resulted in a small quantity of reagent to be held within a manifold line where it was subsequently transferred to the next adjacent reagent. During the evening run approximately a month after pm, the cross contamination of reagents was significant enough to damage approximately one-third of the patient specimens processed that evening, roughly 47 out of 140 total patient specimens. This problem was noticed on the following morning during tissue embedding and microtomy when tissue was discovered to be brittle. The pathologists had difficulty interpreting some of the h&e prepared slides and required steps to be taken to try and salvage the specimens in order to render a diagnosis. As a result of this instrument malfunction the pathologists were unable to provide a diagnosis on two patients, both of which underwent extreme procedures to obtain the specimens for diagnosis. To reiterate: approximately 47 patient specimens had suboptimal tissue processing, attempts to salvage the specimens were not successful, two patient cases had specimens processed so poorly that no diagnosis could be made. Surgical procedures may need to be repeated on these two patients. Manufacturer response for histology tissue processor, logos (per site reporter): manufacturer inspected the device and identified a problem of loose and leaking reagent valve seals resulting from inadequate tightening during the previous maintenance visit. Device was adjusted to correct operation. Manufacturer will inspect the device again in 30 days to confirm that device is still operating properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5758289 |
| MDR Report Key | 5758289 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-04-21 |
| Report Date | 2016-05-24 |
| Date Reported to FDA | 2016-05-24 |
| Date Reported to Mfgr | 2016-05-24 |
| Date Added to Maude | 2016-06-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 3 |
| Brand Name | LOGOS |
| Generic Name | PROCESSOR, TISSUE, AUTOMATED |
| Product Code | FEI |
| Date Received | 2016-06-29 |
| Model Number | LOGOS |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILESTONE MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 6475 TECHNOLOGY AVENUE, SUITE F KALAMAZOO MI 49009 US 49009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-29 |