MalfunctionMRZ
ELITE BIOMEDICAL SOLUTIONS THIRD PARTY PARTS FOR PUMP
Received Nov 14, 2022 · Event occurred Aug 17, 2022
Report MW5113239 · MDR key 15799148
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Elite Biomedical Solutions LlcCatalog number
45245
Product problems
- Product Quality Problem
- Free or Unrestricted Flow
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED A PUMP MODULE HAD A FREE FLOW EVENT. THERE WAS PATIENT INVOLVEMENT BUT PATIENT IMPACT IS UNKNOWN. BD INVESTIGATION WAS PERFORMED ON THE RETURNED SAMPLES, THE PROBABLE CAUSE OF THE COMPLAINT OF FREE FLOW WAS IDENTIFIED AS THE UNAUTHORIZED USE OF THIRD PARTY MANUFACTURED PARTS. THIRD PARTY PARTS WERE MANUFACTURED BY ELITE BIOMEDICAL SOLUTIONS (REAR CASE, BEZEL ASSEMBLY). FDA SAFETY REPORT ID# (B)(4).