MalfunctionPKP

EMED VERA RATE PLUS VERSA RATE PLUS

Received Jun 11, 2025 · Event occurred May 31, 2025

Report MW5171326 · MDR key 22187468

Device

Generic name

Immunoglobulin G (igg) Infusion System

Manufacturer

Emed/emed Technologies Corporation

Lot number

2410033

Product problems

Crack
Leak/Splash

Patient

41 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

SUBCUTANEOUS INFUSION WITH HIZENTRA PREFILLED SYRINGES, THE VERSA RATE PLUS CRACKED AT THE BEGINNING OF THE INFUSION WHICH LED TO THE LOSE OF 10 GRAMS OF MEDICATION. APPARENTLY, THIS IS A KNOWN FLAW WHEN USING THE HIZENTRA PREFILLED SYRINGES WITH THE VERSA RATE PLUS.