inforMED
MalfunctionMEB

INFUSOR

Received Jul 15, 2026 · Event occurred May 27, 2026

Report 1416980-2026-02332 · MDR key 25829055

Device

Generic name

Pump, Infusion, Elastomeric

Model number

2C2009K

Catalog number

2C2009K

Lot number

26B014

Product problems

  • Excess Flow or Over-Infusion

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A LARGE VOLUME INFUSOR OVER-INFUSED; THE INFUSION FINISHED 12 HOURS EARLIER THAN THE EXPECTED 46 HOURS. THIS WAS OBSERVED DURING PATIENT INFUSION VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.