MalfunctionFPB
IV EXT SET 7" 0.2 MICRON FILT
Received Oct 27, 2020
Report MW5097486 · MDR key 10747748
Product problems
- Insufficient Flow or Under Infusion
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
(B)(6) NURSE (B)(6) SPONTANEOUSLY CALLED IN, STATED THAT THE SHE WAS HAVING DIFFICULTIES WITH THE ADMINISTERING THE INFUSION OF ADAKVEO THROUGH THE 2.0 MICRON FILTERS DISPENSED. SHE STATED THAT THE INFUSION WAS SUPPOSED TO TAKE 30 MINS, BUT TOOK 1 HOUR AND 45 MINUTES. SHE STATED THAT SHE OPENED UP THE FILTER ALL THE WAY, BUT IT STILL WAS SLOWLY INFUSED. SHE IS REQUESTING THAT AN ALTERNATIVE BRAND BE SHIPPED AT NEXT FILL TO DECIPHER IF IT'S THE MICRON FILTER ITSELF, OR IF THE ONE THAT WAS USED DURING ADMINISTRATION WAS DEFECTIVE. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.