PROTEK D+ ECLS 31FR CAN
Received Mar 18, 2026 · Event occurred Feb 13, 2026
Report 1718850-2026-90003 · MDR key 24625437
Device
Generic name
Dual Lumen Ecmo Cannula
Manufacturer
Sorin Group Italia SrlModel number
PROTEK D+ ECLS 31FR CANCatalog number
5150-5131
Lot number
UNKNOWN
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A.1.- A.5. PATIENT INFORMATION WAS NOT PROVIDED. D4. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. H11: THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THAT THE CANNULA WAS USED FOR TWO (2) DAYS. AFTER THE CRACK WAS NOTICED, THE CANNULA WAS REPLACED WITH ANOTHER ONE. REPORTEDLY, THE CRACK DID NOT CAUSE ANY LEAKAGE OR FLOW ISSUE. IN ADDITION, THE CANNULA WAS SECURED WITHOUT A SUTURE RING. CUSTOMER REPORTEDLY DID NOT FIX THE PROXIMAL LEGS OF THE CANNULA TOGETHER DURING USE. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
LIVANOVA US RECEIVED REPORT OF A PROTEKDUO CANNULA WHICH CRACKED AT THE Y CONNECTOR DURING USAGE. NO PATIENT IMPACT WAS REPORTED.
Additional Manufacturer Narrative
G1: UPDATED G1 CONTACT OFFICE -(B)(6).
Description of Event or Problem
SEE INITIAL REPORT.