inforMED
DeathIZQ

ULRICH MEDICAL

Received May 2, 2025 · Event occurred Feb 20, 2025

Report 9612420-2025-00101 · MDR key 21948389

Device

Generic name

Patient Hose 250 Cm, 2 Check Valves

Model number

XD 2040

Lot number

E000095

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Anaphylactoid / Anaphylaxis
  • Anaphylactoid / Anaphylaxis

Narrative

Additional Manufacturer Narrative

THE MENTIONED ARTICLE XD 2040 IS NOT SOLD IN THE USA. HOWEVER, XD 2042 IS FUNCTIONALLY IDENTICAL AND IS SOLD IN THE USA. BASED ON THE INFORMATION AVAILABLE, THE DEVICE CAN BE EXCLUDED AS A SOURCE OF ERROR. IT IS APPROVED BY THE AUTHORITIES FOR USE WITH THE SAID CONTRAST MEDIUM. ALL DEVICES ON SITE HAVE SUCCESSFULLY PASSED A TECHNICAL SAFETY TEST, THERE IS NO INDICATION OF A ENDOGENOUS CAUSE OF THE INJECTION SYSTEM.

Description of Event or Problem

ACCORDING TO REPORTING PERSON: "WE HAVE BEEN INFORMED TODAY OF SERIOUS ALLERGIC INCIDENT RESULTING IN THE DEATH OF 1 PATIENT AT THE (B)(6) HOSPITAL. THIS INCIDENT HAS OCCURRED IN FEBRUARY, A PATIENT WAS INJECTED WITH IOMERON USING THE ULRICH INJECTOR. THE PATIENT TUBING XD 2040 ANNOUNCED TO BE INVOLVED COMES FROM BATCH E000095."

Remedial action

  • Inspection