InjuryLKN
SPECTRA OPTIA
Received Jul 16, 2026 · Event occurred Jun 22, 2026
Report 1722028-2026-00107 · MDR key 25845794
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Cramp(s) /Muscle Spasm(s)
- Hypocalcemia
Narrative
Description of Event or Problem
CUSTOMER REPORTED HYPOCALCEMIA THAT REQUIRED AN INTRAVENOUS SUBSTITUTION OF IONIZED CA < 1.0 MMOL/L. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.
Additional Manufacturer Narrative
LOT NUMBER, MANUFACTURE DATE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.