MalfunctionDWB
QUANTUM ROLLER PUMP
Received Dec 4, 2024 · Event occurred Jul 21, 2023
Report 3006073153-2024-00122 · MDR key 20840787
Device
Generic name
Roller Pump
Manufacturer
Spectrum Medical LimitedModel number
QRP6Catalog number
51-000013-00
Product problems
- Pumping Stopped
- Pumping Stopped
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
USER REPORTED SPEED ERROR ON THEIR SUCKER PUMP DURING A CASE. THE USER REPORTED THAT THEY WERE UNABLE TO GET THE PUMP STARTED AGAIN. THERE WAS NO PATIENT HARM AS A RESULT IF THIS MALFUNCTION. WE CONSIDER PUMP STOP A REPORTABLE MALFUNCTION.
Additional Manufacturer Narrative
OPENING UP THE DEVICE REVEALED WHITE RESIDUE THAT WOULD BE INDICITIVE OF LIQUID INGRESS. THE DEVICE DEEMED BEYOND ECONOMICAL REPAIR AND REPLACED.
Remedial action
- Replace