inforMED
MalfunctionMEB

INFUSOR

Received Jun 12, 2026 · Event occurred May 13, 2026

Report 1416980-2026-01984 · MDR key 25485992

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C2063K

Catalog number

2C2063K

Lot number

25H011

Product problems

  • No Flow

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

E1: INITIAL REPORTER POSTAL CODE - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR DID NOT INFUSE PROPERLY (NO FLOW) OVER A 24 HOUR PERIOD. THIS ISSUE OCCURRED DURING PATIENT INFUSION. THE DEVICE WAS FILLED WITH CEFAZOLIN (AFT) 8000MG IN SODIUM CHLORIDE 0.9%. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.