COBE SPECTRA
Report
- Report Number
- 1722028-2024-00371
- Event Type
- Injury
- Date Received
- September 3, 2024
- Date of Event
- November 13, 2019
- Report Date
- September 3, 2024
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- PMA / PMN Number
- BK080035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CATALOG NUMBER, LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CATES, N. C., OAKLEY, D. J., & ONWUEMENE, O. A. (2018). THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL. JOURNAL OF CLINICAL APHERESIS, 33(5), 580¿585. HTTPS://DOI.ORG/10.1002/JCA.21644.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. CATALOG NUMBER, LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. 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. THIS JOURNAL WAS PUBLISHED IN 2019, THE CURRENT DEVICES IN FIELD HAVE PRODUCT AND SOFTWARE CHANGES THAT WERE NOT IN PLACE FOR DEVICES USED MORE THAN 5 YEARS AGO. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT. CATES, N. C., OAKLEY, D. J., & ONWUEMENE, O. A. (2018). THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL. JOURNAL OF CLINICAL APHERESIS, 33(5), 580¿585. HTTPS://DOI.ORG/10.1002/JCA.21644.
THIS REPORT IS BEING FILED TO PROVIDE A CORRECTION IN D.2B. CATALOG NUMBER, LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. 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. THIS JOURNAL WAS PUBLISHED IN 2019, THE CURRENT DEVICES IN FIELD HAVE PRODUCT AND SOFTWARE CHANGES THAT WERE NOT IN PLACE FOR DEVICES USED MORE THAN 5 YEARS AGO. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT. CATES, N. C., OAKLEY, D. J., & ONWUEMENE, O. A. (2018). THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL. JOURNAL OF CLINICAL APHERESIS, 33(5), 580¿585. HTTPS://DOI.ORG/10.1002/JCA.21644.
PER JOURNAL ARTICLE "THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL". BY NANCY C. CATES, , DARLENE J. OAKLEY, , OLUWATOYOSI A. ONWUEMENE, ABSTRACT THE SPECTRA OPTIA APHERESIS SYSTEM® HAS ONLY RECENTLY BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) FOR THERAPEUTIC WHITE BLOOD CELL (WBC) AND IS NOT YET APPROVED FOR PLATELET DEPLETIONS. PRIOR TO FDA-APPROVAL OF THE WBC DEPLETION PROTOCOL, WHEN OUR AVAILABLE COBE SPECTRA APHERESIS SYSTEMS WERE OUT OF SERVICE, WE SUCCESSFULLY PERFORMED WBC DEPLETION USING A MODIFIED SPECTRA OPTIA APHERESIS SYSTEM CONTINUOUS MONONUCLEAR CELL (CMNC) PROTOCOL. USING THIS MODIFIED SPECTRA OPTIA CMNC PROTOCOL, WE CREATED INSTITUTIONAL PROTOCOLS FOR WBC AND PLATELET DEPLETIONS. WE PERFORMED 10 WBC DEPLETIONS IN 9 PATIENTS AND 2 PLATELET DEPLETIONS IN 2 PATIENTS. WE COMPARED PRE- AND POST-PROCEDURE WBC, PLATELET COUNT, AND HEMOGLOBIN TO THE SAME DATA FROM PATIENTS PREVIOUSLY TREATED ON THE COBE SPECTRA AND FOUND NO DIFFERENCE IN % WBC AND PLATELET REDUCTION. WE ALSO FOUND NO SIGNIFICANT DIFFERENCE IN POST-PROCEDURAL HEMATOCRIT DECLINE. ADDITIONALLY, ADVERSE REACTIONS WERE NOT INCREASED. THEREFORE, WE CONCLUDE THAT THE SPECTRA OPTIA CMNC PROTOCOL CAN BE SUCCESSFULLY MODIFIED FOR EFFECTIVE WBC AND PLATELET DEPLETIONS WITHOUT INCREASE IN ADVERSE REACTIONS. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE 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 "THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL". BY NANCY C. CATES, , DARLENE J. OAKLEY, , OLUWATOYOSI A. ONWUEMENE, ABSTRACT THE SPECTRA OPTIA APHERESIS SYSTEM® HAS ONLY RECENTLY BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) FOR THERAPEUTIC WHITE BLOOD CELL (WBC) AND IS NOT YET APPROVED FOR PLATELET DEPLETIONS. PRIOR TO FDA-APPROVAL OF THE WBC DEPLETION PROTOCOL, WHEN OUR AVAILABLE COBE SPECTRA APHERESIS SYSTEMS WERE OUT OF SERVICE, WE SUCCESSFULLY PERFORMED WBC DEPLETION USING A MODIFIED SPECTRA OPTIA APHERESIS SYSTEM CONTINUOUS MONONUCLEAR CELL (CMNC) PROTOCOL. USING THIS MODIFIED SPECTRA OPTIA CMNC PROTOCOL, WE CREATED INSTITUTIONAL PROTOCOLS FOR WBC AND PLATELET DEPLETIONS. WE PERFORMED 10 WBC DEPLETIONS IN 9 PATIENTS AND 2 PLATELET DEPLETIONS IN 2 PATIENTS. WE COMPARED PRE- AND POST-PROCEDURE WBC, PLATELET COUNT, AND HEMOGLOBIN TO THE SAME DATA FROM PATIENTS PREVIOUSLY TREATED ON THE COBE SPECTRA AND FOUND NO DIFFERENCE IN % WBC AND PLATELET REDUCTION. WE ALSO FOUND NO SIGNIFICANT DIFFERENCE IN POST-PROCEDURAL HEMATOCRIT DECLINE. ADDITIONALLY, ADVERSE REACTIONS WERE NOT INCREASED. THEREFORE, WE CONCLUDE THAT THE SPECTRA OPTIA CMNC PROTOCOL CAN BE SUCCESSFULLY MODIFIED FOR EFFECTIVE WBC AND PLATELET DEPLETIONS WITHOUT INCREASE IN ADVERSE REACTIONS. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE 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 "THERAPEUTIC WHITE BLOOD CELL AND PLATELET DEPLETIONS USING THE SPECTRA OPTIA SYSTEM CONTINUOUS MONONUCLEAR CELL PROTOCOL". BY NANCY C. CATES, , DARLENE J. OAKLEY, , OLUWATOYOSI A. ONWUEMENE, ABSTRACT THE SPECTRA OPTIA APHERESIS SYSTEM® HAS ONLY RECENTLY BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) FOR THERAPEUTIC WHITE BLOOD CELL (WBC) AND IS NOT YET APPROVED FOR PLATELET DEPLETIONS. PRIOR TO FDA-APPROVAL OF THE WBC DEPLETION PROTOCOL, WHEN OUR AVAILABLE COBE SPECTRA APHERESIS SYSTEMS WERE OUT OF SERVICE, WE SUCCESSFULLY PERFORMED WBC DEPLETION USING A MODIFIED SPECTRA OPTIA APHERESIS SYSTEM CONTINUOUS MONONUCLEAR CELL (CMNC) PROTOCOL. USING THIS MODIFIED SPECTRA OPTIA CMNC PROTOCOL, WE CREATED INSTITUTIONAL PROTOCOLS FOR WBC AND PLATELET DEPLETIONS. WE PERFORMED 10 WBC DEPLETIONS IN 9 PATIENTS AND 2 PLATELET DEPLETIONS IN 2 PATIENTS. WE COMPARED PRE- AND POST-PROCEDURE WBC, PLATELET COUNT, AND HEMOGLOBIN TO THE SAME DATA FROM PATIENTS PREVIOUSLY TREATED ON THE COBE SPECTRA AND FOUND NO DIFFERENCE IN % WBC AND PLATELET REDUCTION. WE ALSO FOUND NO SIGNIFICANT DIFFERENCE IN POST-PROCEDURAL HEMATOCRIT DECLINE. ADDITIONALLY, ADVERSE REACTIONS WERE NOT INCREASED. THEREFORE, WE CONCLUDE THAT THE SPECTRA OPTIA CMNC PROTOCOL CAN BE SUCCESSFULLY MODIFIED FOR EFFECTIVE WBC AND PLATELET DEPLETIONS WITHOUT INCREASE IN ADVERSE REACTIONS. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE 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 |
|---|---|---|---|---|---|---|---|
| 1342177 | COBE SPECTRA | SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC | LKN | TERUMO BCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |