1 Returned Product Analysis Kyle DelloRusso
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Returned Product Analysis
Kyle DelloRusso
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Kyle DelloRusso
• RPA Tech Intern • Objectives:
– Professional Knowledge and Experience – Outside perspective
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Returned Product Analysis (RPA)
• Regulatory – Post Market Surveillance • Complaint Investigations:
– Physically Evaluated – Functionally Tested – Evidence Collected – Investigation Report
• Reportable Complaints
Presenter
Presentation Notes
- RPA department falls under mandatory regulation established by the FDA to continually monitor products on the market to ensure safety. - When a complaint with the product is reported, Thoratec requests that the product to be returned so that the product and event can be investigated. -The product goes through several steps when undergoing an investigation. - Reportable complaints need to be reported to the FDA, the FDA uses this information to make decisions regarding the product and it’s availability on the market. The FDA can use this information, if deemed serious enough to issue a recall. Companies can also use this information to issue company mandated recalls
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Electronics Lab
• HMII Pocket Controllers • HMIII Controllers • Patient Cables • EPC Controllers • Power Modules • Display Modules • Batteries/ Clips
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Pocket Controller (PC)
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Presentation Notes
1. Pocket controllers are the most widely used controllers for the HMII
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Preliminary Evaluation
Presenter
Presentation Notes
After a PC is returned, the first step is to do a preliminary evaluation of the controller. The log file is collected, any physical abnormalities are noted, and the initial values are recorded. The purpose of the prelim is to see if the event in the complaint can be initially confirmed or observed.
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Functional Testing
Presenter
Presentation Notes
If the controller is functioning well enough, or the complaint cannot be confirmed in the preliminary evaluation, it undergoes functional testing. The purpose of functional testing is to see if the controller functioned as intended by alarming under the right circumstances. Power supplies, a test box, a mock loop, and a data viewer are used to simulate events which would cause an alarm and to monitor the results. This is another step trying to recreate the event reported in the complaint.
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Burn-In
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Presentation Notes
After testing, the product may be placed on a burn in: a burn in is where the controller is hooked up to a mock loop with a pump and is run for at least 4 hours. If the event is not recreated during testing or prelims, the controller will be burned in to see if the alarm will trigger again.
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Troubleshooting
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Presentation Notes
After burn in, if the event cannot be recreated, the PC is taken apart to troubleshoot. This step is to see if any component on the board had ESD or another malfunction.
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Bio Lab
• Percutaneous Leads • HMII Pumps
Presenter
Presentation Notes
HMIIs and Perc leads are the primary products looked at in the Bio Lab. Pumps are returned in the event of: a patient death, a pump exchange, or due to a heart transplant. The pump above was returned after a patient death, and you can see the adhesion of a lot of tissue.
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Initial Evaluation
Presenter
Presentation Notes
After a pump is received, and an investigator and a tech will take the pump apart to do an initial evaluation. The tech will disassemble the pump while the investigator takes pictures and makes notes of any abnormalities (i.e. thrombus, ect.)
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Incubator/Soup
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Presentation Notes
The disassembled pump will be placed in a solution of tyrgazine and water for 48 hours to initially clean the human tissue off of the pump. 3. Any blood clots found in the pump will be preserved in a solution for the investigator to look at later
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Oven
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Presentation Notes
After the pump has sat in the “soup” for the designated time, it is moved to the oven to dry off.
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Clean
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Presentation Notes
1. Once the pump is ready to be tested, isopropyl alcohol will be used to clean the remaining human tissue from the pump, primarily around the bearings.
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Sonicator
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Presentation Notes
1. If the bearings cannot be removed, the disassembled pump will be placed in the sonicator for approx. 15 minutes to loosen up the bearings.
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Clean and Rebuild
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Presentation Notes
1. Once the bearings from the impeller, inlet, and outlet side are removed, they are thoroughly cleaned with alcohol and q-tips.
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Rebuild
Presenter
Presentation Notes
The clean pump is then reassembled and checked to make sure that the impeller can freely spin. If the impeller does not freely spin, the process of cleaning an rebuilding is repeated as necessary.
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Soldering
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Presentation Notes
The pumps can be returned in 3 states regarding percutaneous leads: a pump fully attached to a perc lead, a pump severed from the perc lead, or a severed pump with no perc lead returned. If severed, either the severed perc lead or a test one is tested for continuity and then soldered onto the pump. Heat wrap is used to insulate the exposed wire and solder.
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Functional Testing
Presenter
Presentation Notes
For functional testing, the pump is set up to a calibrated mock loop which includes: System monitor, power module, system controller, patient cable, pressure transducer, and a water loop. The pump is set up and then tested for the pressure drop and the power at 3 different speeds (8000, 10000, 12000rpm) to ensure that it meets the product standards.
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Sanitizer
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Presentation Notes
The pumps are then sanitized and places in storage. Reports are written and reportable ones are sent to the FDA
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Reflections
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Presentation Notes
Great Aspects: Interaction with the department Labs Improvements: Include more visual training (i.e. similar to a photographic powerpoint) Final Views: Broadened views
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Thank You, Any Questions?
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