MAUDE Adverse Event Report: MILESTONE MEDICAL TECHNOLOGIES, INC. LOGOS; PROCESSOR, TISSUE, AUTOMATED

Model Number LOGOS

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 04/21/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: LOGOS
• Type of Device: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): MILESTONE MEDICAL TECHNOLOGIES, INC.; 6475 technology avenue, suite f; kalamazoo MI 49009
• MDR Report Key: 5758289
• MDR Text Key: 48434847
• Report Number: 5758289
• Device Sequence Number: 1
• Product Code: FEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LOGOS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO