inforMED
MalfunctionMEB

INFUSOR

Received Jul 2, 2026 · Event occurred May 31, 2026

Report 1416980-2026-02224 · MDR key 25699940

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C2063K

Catalog number

2C2063K

Lot number

25J030

Product problems

  • Filling Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR UNDER INFUSED DURING INFUSION. THE EXPECTED THERAPY TIME WAS 24 HOURS; HOWEVER, IT WAS OBSERVED THAT ONLY HALF THE MEDICATION WAS DELIVERED WHEN THE PATIENT RETURNED TO THE HOSPITAL TO DISCONNECT THE DEVICE THE NEXT DAY. THE DEVICE WAS FILLED WITH CEFAZOLIN (AFT) 6000MG IN SODIUM CHLORIDE 0.9% 240ML TOTAL VOLUME. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.