MEDFUSION 3000 SERIES
Received May 5, 2023 · Event occurred Sep 1, 2021
Report 3012307300-2023-05203 · MDR key 16878281
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
St PaulCatalog number
67-2515-51
Lot number
P0754077
Product problems
- Mechanical Problem
- Smoking
- Mechanical Problem
- Smoking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: UDI IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUALLY INSPECTED ALL BATTERIES, PLUGGED EACH BATTERY IN A TEST PUMP AND CHARGED FOR A FEW MINUTES, CHECKED BATTERY DIAGNOSTICS. DETECTED NO SMOKE OR ANY DAMAGE. ONLY 1 OUT OF 6 BATTERIES HAD "BATTERY NOT WORKING" ALARM OCCUR WITH ALL BATTERY VALUES ZERO. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED AS THE REPORTED ISSUE COULD NOT BE REPLICATED AT THE TIME OF THE DEVICE EVALUATION. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: ALL 6 BATTERIES WERE SCRAPPED.
Description of Event or Problem
IT WAS REPORTED THAT THE BATTERIES CAUSED THE MACHINE SMOKE AND WOULDN'T WORK. NO PATIENT INJURY REPORTED.