MalfunctionNHV
NEPHROS
Received May 29, 2019 · Event occurred Apr 29, 2019
Report 3003337893-2019-00001 · MDR key 8652580
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bacterial Infection
- Bacterial Infection
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS UNDERWAY. WE ARE AWAITING FINAL INVESTIGATION RESULTS AND LABORATORY RESULTS. UPON COMPLETION, THE INFORMATION WILL BE REVIEWED AND THE FINDING PUBLISHED. ANTICIPATED COMPLETION DATE: JUNE 07TH 2019.
Description of Event or Problem
THE INVESTIGATION IS CURRENTLY UNDERWAY. THE MANUFACTURE WAS INFORMED THAT THE CUSTOMER EXPERIENCED A POSITIVE LEGIONELLA RESULT.
Remedial action
- Replace