MEDFUSION INFUSION PUMP
Received Nov 21, 2024 · Event occurred Oct 30, 2024
Report 3012307300-2024-13803 · MDR key 20750346
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
4000-0105-51
Product problems
- Failure to Infuse
- Failure to Infuse
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56, WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED, THAT THE DEVICE WAS ALARMING AND WILL NOT TURN OFF. THE SCREEN LIGHTS UP, BUT DOES NOT DISPLAY ANYTHING. SO, THERE IS NO WAY TO GO THROUGH THE SETTINGS. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ONE DEVICE WAS RETURNED FOR REPAIR WITH COMPLAINT THAT DEVICE WAS ALARMING AND WILL NOT TURN OFF. COMPLAINT CONFIRMED WHILE POWERING ON PUMP AND EXPERIENCING THE SAME RESULTS. TESTED ALL COMPONENTS AND FOUND A BAD MAIN PRINTED CIRCUIT BOARD (PCB), CLUTCH SET, PLUNGER CASE AND A NOISY MOTOR. THE ISSUES WERE FIXED BY REPLACING THOSE PARTS ACCORDINGLY. DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS.