SPECTRA OPTIA
Report
- Report Number
- 1722028-2025-00193
- Event Type
- Malfunction
- Date Received
- August 25, 2025
- Date of Event
- October 12, 2015
- Report Date
- August 25, 2025
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583123205
- PMA / PMN Number
- K183081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR IS THERE A LIKELY POTENTIAL FOR DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS CONSIDERED SUCCESSFUL. THE PATIENT WENT ON TO HAVE ANOTHER 2 ROUNDS OF LEUKAPHERESIS AND WAS DISCHARGED. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT. CITATION: WANG, M. L., DAVENPORT, R. D., & YAMADA, C. (2015). COMPARISON OF TWO LEUKOCYTAPHERESIS PROTOCOLS IN A CASE OF IDIOPATHIC HYPEREOSINOPHILIC SYNDROME. JOURNAL OF CLINICAL APHERESIS, 31(5), 481¿489. HTTPS://DOI.ORG/10.1002/JCA.21435.
LOT NUMBER, MANUFACTURE DATE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: WANG, M. L., DAVENPORT, R. D., & YAMADA, C. (2015). COMPARISON OF TWO LEUKOCYTAPHERESIS PROTOCOLS IN A CASE OF IDIOPATHIC HYPEREOSINOPHILIC SYNDROME. JOURNAL OF CLINICAL APHERESIS, 31(5), 481¿489. HTTPS://DOI.ORG/10.1002/JCA.21435.
PER JOURNAL ARTICLE "COMPARISON OF TWO LEUKOCYTAPHERESIS PROTOCOLS IN A CASE OF IDIOPATHIC HYPEREOSINOPHILIC SYNDROME" BY MICHAEL L. WANG, ROBERTSON D. DAVENPORT, AND CHISA YAMADA BACKGROUND: HYPEREOSINOPHILIC SYNDROME (HEOS) IS RARE, AND THE EFFICACY OF LEUKOCYTAPHERESIS IN THIS CONTEXT IS UNCLEAR. WE HERE REPORT THE SUCCESSFUL TREATMENT OF A PATIENT WITH IDIOPATHIC HEOS WITH FOUR LEUKOCYTAPHERESIS PROCEDURES USING TWO PROTOCOLS. CASE: A 4-YEAR-OLD FEMALE PRESENTED WITH CARDIAC AND RESPIRATORY DYSFUNCTION, AND WBC OF 225 K/LL WITH 96% EOSINOPHILS. LEUKOCYTAPHERESIS WAS STARTED AFTER INITIATION OF METHYLPREDNISOLONE AND HYDROXYUREA. SHE RECEIVED TWO LEUKOCYTAPHERESIS WITH POLYMORPHONUCLEAR CELL (PMN) PROTOCOL, FOLLOWED BY INITIATION OF IMATINIB THERAPY, THEN TWO LEUKOCYTAPHERESIS WITH MONONUCLEAR CELL (MNC) PROTOCOL. AFTER THE FOURTH LEUKOCYTAPHERESIS, HER WBC DECREASED TO 69 K/LL WITH 82% EOSINOPHILS. SHE WAS DISCHARGED ON HOSPITAL DAY 21 UNDER STABLE CONDITION WITH WBC OF 22 K/LL WITH 86% EOSINOPHILS. WBC COUNT AND EOSINOPHIL PERCENTAGE CONTINUED TO DECREASE, AND WERE 6.4 K/LL AND 52% BY 2 WEEKS AND 3.9 K/LL AND 4.9% BY 3 MONTHS AFTER DISCHARGE, RESPECTIVELY. FINDINGS: WBC AND ABSOLUTE EOSINOPHIL (AEO) COUNTS DECREASED BY AN AVERAGE OF 29.0 AND 30.4% PER LEUKOCYTAPHERESIS, RESPECTIVELY. NORMALIZED TO ESTIMATED BLOOD VOLUME, PROCEDURES WITH PMN AND MNC PROTOCOLS CHANGED, ON AVERAGE, WBC BY 210.7 AND 212.1%, AEO BY 210.4 AND 213.4%, PLATELET BY 28.1 AND 219.2%, AND FLUID BALANCE BY 2129 AND 247 ML, RESPECTIVELY. CONCLUSION: LEUKOCYTAPHERESIS WAS EFFECTIVE IN DECREASING WBC AND AEO COUNTS IN HEOS, WITH PMN AND MNC PROTOCOLS ACHIEVING SIMILAR REDUCTIONS. HOWEVER, PMN PROTOCOL RESULTED IN GREATER NEGATIVE FLUID BALANCE AND MNC PROTOCOL RESULTED IN GREATER PLATELET LOSS. SPECIFIC DETAILS, SUCH AS FURTHER PATIENT INFORMATION WAS NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
PER JOURNAL ARTICLE "COMPARISON OF TWO LEUKOCYTAPHERESIS PROTOCOLS IN A CASE OF IDIOPATHIC HYPEREOSINOPHILIC SYNDROME" BY MICHAEL L. WANG, ROBERTSON D. DAVENPORT, AND CHISA YAMADA BACKGROUND: HYPEREOSINOPHILIC SYNDROME (HEOS) IS RARE, AND THE EFFICACY OF LEUKOCYTAPHERESIS IN THIS CONTEXT IS UNCLEAR. WE HERE REPORT THE SUCCESSFUL TREATMENT OF A PATIENT WITH IDIOPATHIC HEOS WITH FOUR LEUKOCYTAPHERESIS PROCEDURES USING TWO PROTOCOLS. CASE: A 4-YEAR-OLD FEMALE PRESENTED WITH CARDIAC AND RESPIRATORY DYSFUNCTION, AND WBC OF 225 K/LL WITH 96% EOSINOPHILS. LEUKOCYTAPHERESIS WAS STARTED AFTER INITIATION OF METHYLPREDNISOLONE AND HYDROXYUREA. SHE RECEIVED TWO LEUKOCYTAPHERESIS WITH POLYMORPHONUCLEAR CELL (PMN) PROTOCOL, FOLLOWED BY INITIATION OF IMATINIB THERAPY, THEN TWO LEUKOCYTAPHERESIS WITH MONONUCLEAR CELL (MNC) PROTOCOL. AFTER THE FOURTH LEUKOCYTAPHERESIS, HER WBC DECREASED TO 69 K/LL WITH 82% EOSINOPHILS. SHE WAS DISCHARGED ON HOSPITAL DAY 21 UNDER STABLE CONDITION WITH WBC OF 22 K/LL WITH 86% EOSINOPHILS. WBC COUNT AND EOSINOPHIL PERCENTAGE CONTINUED TO DECREASE, AND WERE 6.4 K/LL AND 52% BY 2 WEEKS AND 3.9 K/LL AND 4.9% BY 3 MONTHS AFTER DISCHARGE, RESPECTIVELY. FINDINGS: WBC AND ABSOLUTE EOSINOPHIL (AEO) COUNTS DECREASED BY AN AVERAGE OF 29.0 AND 30.4% PER LEUKOCYTAPHERESIS, RESPECTIVELY. NORMALIZED TO ESTIMATED BLOOD VOLUME, PROCEDURES WITH PMN AND MNC PROTOCOLS CHANGED, ON AVERAGE, WBC BY 210.7 AND 212.1%, AEO BY 210.4 AND 213.4%, PLATELET BY 28.1 AND 219.2%, AND FLUID BALANCE BY 2129 AND 247 ML, RESPECTIVELY. CONCLUSION: LEUKOCYTAPHERESIS WAS EFFECTIVE IN DECREASING WBC AND AEO COUNTS IN HEOS, WITH PMN AND MNC PROTOCOLS ACHIEVING SIMILAR REDUCTIONS. HOWEVER, PMN PROTOCOL RESULTED IN GREATER NEGATIVE FLUID BALANCE AND MNC PROTOCOL RESULTED IN GREATER PLATELET LOSS. SPECIFIC DETAILS, SUCH AS FURTHER PATIENT INFORMATION WAS NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 216238 | SPECTRA OPTIA | SPECTRA OPTIA IDL SET | LKN | TERUMO BCT | 05020583123205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Female | Other |