Spectra Optia® 10300Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05020583103009), received between Nov 30, 2018 and Oct 29, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "EXTRACORPOREAL PHOTOPHERESIS IN PEDIATRIC AND ADULT PATIENTS WITH GRAFT-VERSUS-HOST DISEASE" BY ALEXANDRA IONETE, MARIUS SURLEAC, MIHAELA UTA, ZSOFIA VARADY, ANA MARIA BICA, CRISTINA GEORGIANA JERCAN, ANCA COLITA AND DANIEL CORIU POTENTIAL ADVERSE EVENT: WBC COUNTS DECREASED DURING THE ECP TREATMENT, DROPPING FROM A MEDIAN OF 4.4 × 109/L (RANGE: 1.7¿9 × 109/L) BEFORE TREATMENT TO 3.95 × 109 G/DL (RANGE: 1.1¿8.8 × 109/L) AFTER TREATMENT (P = 0.0251). HEMOGLOBIN LEVELS ALSO DECREASED FROM A MEDIAN OF 9 G/DL (RANGE: 7.6¿15.2) BEFORE TREATMENT TO A MEDIAN OF 8.6 (RANGE: 6.8¿16.4) AFTER TREATMENT (NOT STATISTICALLY SIGNIFICANT, NS). HEMATOCRIT LEVELS REMAINED STABLE, WITH A MEDIAN OF 26.1% (RANGE: 21.1¿43.6) BEFORE TREATMENT, DROPPING TO 24.2% (RANGE: 19.6¿39.6) AFTER TREATMENT (P = <0.0001). THROMBOCYTE COUNTS DECREASED FROM A MEDIAN OF 69.65 × 109/L (RANGE: 12¿409.6) BEFORE TREATMENT TO A MEDIAN OF 52.7 × 109/L (RANGE: 10¿327.5 × 109/L) AFTER TREATMENT (P = <0.0001). PREVIOUS RESEARCH HAS REVEALED COMPARABLE FINDINGS ON BLOOD PARAMETERS [26]. WHILE ECP CAN HAVE AN IMPACT ON THE LEVELS OF HEMOGLOBIN, HEMATOCRIT, LEUKOCYTES, LYMPHOCYTES, AND THROMBOCYTES, NOT ALL CH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20559667 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN ALLOGENIC CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION ON THE SPECTRA OPTIA DEVICE, A DONOR EXPERIENCED SHIVERING, BACK PAIN AND PAIN IN LOWER LIMB. PER THE CUSTOMER, THIS DONOR REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE DONOR WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED IV "EMSET" INJECTION, IV AVIL INJECTION, BOLOS IV CALCIUM, AND CROCIN TABLET AS A RESULT OF THE REACTION. PER THE CUSTOMER, THE DONOR IS REPORTED AS "OK". DONOR¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient; Reaction

  MAUDE report 8120348 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN AUTOLOGOUS CONTINUOUS MONONUCLEAR CELL (CMNC)COLLECTION ON THE SPECTRA OPTIA DEVICE, A PATIENT EXPERIENCED HYPERTENSION. PER THE CUSTOMER,THIS PATIENT REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE PATIENT WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED NORMAL SALINE AS A RESULT OF THE REACTION. PER THE CUSTOMER, THE PATIENT IS REPORTED AS "OK".PATIENT¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: High Blood Pressure/ Hypertension; No Known Impact Or Consequence To Patient

  MAUDE report 8120342 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN AUTOLOGOUS CONTINUOUS MONONUCLEAR CELL (CMNC)COLLECTION ON THE SPECTRA OPTIA DEVICE, A PATIENT EXPERIENCED MILD SHIVERING. PER THE CUSTOMER,THIS PATIENT REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE PATIENT WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED BOLOS CALCIUM AS A RESULT OF THE REACTION. PATIENT OUTCOME IS NOT AVAILABLE AT THIS TIME. PATIENT¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Reaction

  MAUDE report 8120334 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN AUTOLOGOUS CONTINUOUS MONONUCLEAR CELL (CMNC)COLLECTION ON THE SPECTRA OPTIA DEVICE, A PATIENT EXPERIENCED SHIVERING, VOMITING AND HEADACHE. PER THE CUSTOMER, THIS PATIENT REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV)OF THE PATIENT WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED NORMAL SALINE, IV EMSET INJECTION, IV PANTOCID, IV AVIL AND IV PARACETAMOL AS A RESULT OF THE REACTION. PER THE CUSTOMER,THE PATIENT IS REPORTED AS "OK".PATIENT¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Headache; No Known Impact Or Consequence To Patient; Vomiting

  MAUDE report 8120267 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN AUTOLOGOUS CONTINUOUS MONONUCLEAR CELL (CMNC)COLLECTION ON THE SPECTRA OPTIA DEVICE, A PATIENT EXPERIENCED SHIVERING. PER THE CUSTOMER, THIS PATIENT REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE PATIENT WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED IV EMSET INJECTION, IV AVIL INJECTION AND IV PARACETAMOL AS A RESULT OF THE REACTION. PATIENT OUTCOME IS NOT AVAILABLE AT THIS TIME. PATIENT¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Reaction

  MAUDE report 8120257 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN ALLOGENIC CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION ON THE SPECTRA OPTIA DEVICE, A DONOR EXPERIENCED MILD CHILLS. PER THE CUSTOMER, THIS DONOR REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE DONOR WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED IV EMSET INJECTION AND IV AVIL INJECTION AS A RESULT OF THE REACTION. PER THE CUSTOMER, THE DONOR IS REPORTED AS "OK".DONOR¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Chills; No Known Impact Or Consequence To Patient; Reaction

  MAUDE report 8120246 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN ALLOGENIC CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION ON THE SPECTRA OPTIA DEVICE, A DONOR EXPERIENCED SHIVERING, VOMITING AND MINOR FEVER. PER THE CUSTOMER, THIS DONOR REACTION OCCURED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE PATIENT WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED IV AVIL INJECTION, BOLOS IV CALCIUM, IV MAGNESIUM SULPHATE, IV PARACETAMOL AND IV RANITIDINE INJECTION AS A RESULT OF THE REACTION. PER THE CUSTOMER, THE DONOR IS REPORTED AS "OK". DONOR¿S AGE AND IDENTIFIER ARE NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Fever; No Known Impact Or Consequence To Patient; Vomiting

  MAUDE report 8120239 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING AN ALLOGENIC CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION ON THE SPECTRA OPTIA DEVICE, A DONOR EXPERIENCED SHIVERING, FEELING NAUSEA AND VOMITED. PER THE CUSTOMER, THIS DONOR REACTION OCCURRED AFTER ONE TOTAL BLOOD VOLUME (TBV) OF THE PATIENT WAS PROCESSED. THE DOCTOR AT THE CUSTOMER SITE ORDERED IV MAGNESIUM SULPHATE, IVEM SET INJ., NORMAL SALINE, AND IV PARACETAMOL AS A RESULT OF THE REACTION. PER THE CUSTOMER, THE DONOR'S CONDITION IS REPORTED AS "NORMAL".DONOR¿S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE SPECTRA OPTIA SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Nausea; No Known Impact Or Consequence To Patient; Vomiting

  MAUDE report 8120232 ↗