Spectra Optia
Received Jul 13, 2026 · Event occurred May 23, 2026
Report 1722028-2026-00096 · MDR key 25802051
Device
Generic name
Spectra Optia Exchange Set
Manufacturer
Terumo BctCatalog number
4102204
Lot number
2509083144
Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
42 YR · Male
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Rash
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem
CUSTOMER REPORTED THAT WITHIN ONE HOUR OF A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THE PATIENT HAD AN ALLERGIC REACTION AND DEVELOPED RASHES AND ITCHING. THE PATIENT WAS GIVEN HYDROCAR AND AVIL INJECTION BY THE CRITICAL CARE DIRECTOR. PATIENT IDENTIFIER IS UNKNOWN AT THIS TIME. PER CUSTOMER PATIENT STATUS "STILL HOSPITALIZED. INITIALLY PATIENT WAS SICK. PATIENT IS CANDIDATE FOR LIVER TRANSPLANT AND HE IS STILL ADMITTED IN THE HOSPITAL." THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.