SPECTRA OPTIA
Report
- Report Number
- 1722028-2023-00233
- Event Type
- Injury
- Date Received
- July 13, 2023
- Date of Event
- June 10, 2023
- Report Date
- July 13, 2023
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583102200
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION PRESENTING DATA OF A RETROSPECTIVE ANALYSIS OF CLINICAL AND HPC COLLECTION DATA FROM AUTOLOGOUS AND ALLOGENEIC PEDIATRIC DONORS WEIGHING <25 KG COLLECTED ON SPECTRA OPTIA PLATFORM USING THE CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROGRAM FROM 2020 THROUGH 2022, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. THE REPORTED ADVERSE REACTIONS ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARESTHESIA (TINGLING) BUT PATIENTS MAY ALSO EXPERIENCE UNUSUAL TASTE, NAUSEA, LIGHTHEADEDNESS, SHIVERING, AND TREMORS. SEVERE HYPOCALCEMIA MAY ALSO CAUSE MUSCLE CONTRACTIONS AND CAN PROGRESS TO TETANY AND SEIZURES IF HYPOCALCEMIA ESCALATES AND IS NOT CORRECTED. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. KONDO, TAKUMI, ET AL. ¿EFFICIENT GRANULOCYTE COLLECTION METHOD USING HIGH CONCENTRATIONS OF MEDIUM MOLECULAR WEIGHT HYDROXYETHYL STARCH.¿ TRANSFUSION, WILEY-BLACKWELL, JUNE 2023, HTTPS://DOI.ORG/10.1111/TRF.17450.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION PRESENTING DATA OF A RETROSPECTIVE ANALYSIS OF CLINICAL AND HPC COLLECTION DATA FROM AUTOLOGOUS AND ALLOGENEIC PEDIATRIC DONORS WEIGHING <25 KG COLLECTED ON SPECTRA OPTIA PLATFORM USING THE CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROGRAM FROM 2020 THROUGH 2022, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. THE REPORTED ADVERSE REACTIONS ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARESTHESIA (TINGLING) BUT PATIENTS MAY ALSO EXPERIENCE UNUSUAL TASTE, NAUSEA, LIGHTHEADEDNESS, SHIVERING, AND TREMORS. SEVERE HYPOCALCEMIA MAY ALSO CAUSE MUSCLE CONTRACTIONS AND CAN PROGRESS TO TETANY AND SEIZURES IF HYPOCALCEMIA ESCALATES AND IS NOT CORRECTED. THE MEDIAN GRANULOCYTE COLLECTION EFFICIENCY (CE) WAS APPROXIMATELY 24.0% AND 28.1% IN THE M0.8 AND HHES GROUPS, RESPECTIVELY, WHICH WERE SIGNIFICANTLY HIGHER THAN THOSE IN THE M0.46, M0.44, AND M0.37 GROUPS. ONE MONTH FOLLOWING GRANULOCYTE COLLECTION WITH HES130/0.4, NO SIGNIFICANT CHANGES WERE OBSERVED IN SERUM CREATININE LEVELS COMPARED TO THOSE BEFORE THE DONATION. THEREFORE, WE PROPOSE A GRANULOCYTE COLLECTION APPROACH EMPLOYING HES130/0.4, WHICH IS COMPARABLE TO THE USE OF HHES IN TERMS OF THE GRANULOCYTE CE. A HIGH CONCENTRATION OF HES130/0.4 IN THE SEPARATION CHAMBER WAS CONSIDERED CRUCIAL FOR GRANULOCYTE COLLECTION. KONDO, TAKUMI, ET AL. ¿EFFICIENT GRANULOCYTE COLLECTION METHOD USING HIGH CONCENTRATIONS OF MEDIUM MOLECULAR WEIGHT HYDROXYETHYL STARCH.¿ TRANSFUSION, WILEY-BLACKWELL, JUNE 2023, HTTPS://DOI.ORG/10.1111/TRF.17450. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE REPORTED CITRATE REACTIONS. THESE REACTIONS OCCUR DUE TO DECREASED IONIZED CALCIUM IN CIRCULATION AS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY DONOR PHYSIOLOGY, THE RATE OF AC INFUSION, AND/OR THE LENGTH OF THE PROCEDURE. THESE SYMPTOMS MAY BE TREATED WITH ORAL OR INTRAVENOUS CALCIUM SUPPLEMENTS OR BY ADJUSTING THE AC INFUSION RATE.
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. KONDO, TAKUMI, ET AL. ¿EFFICIENT GRANULOCYTE COLLECTION METHOD USING HIGH CONCENTRATIONS OF MEDIUM MOLECULAR WEIGHT HYDROXYETHYL STARCH.¿ TRANSFUSION, WILEY-BLACKWELL, JUNE 2023, HTTPS://DOI.ORG/10.1111/TRF.17450.
PER JOURNAL ARTICLE "EFFICIENT GRANULOCYTE COLLECTION METHOD USING HIGH CONCENTRATIONS OF MEDIUM MOLECULAR WEIGHT HYDROXYETHYL STARCH." BY KONDO ET. AL CITRATE REACTIONS DURING GRANULOCYTE APHERESIS WERE RECORDED IN 1 OF 8 PROCEDURES IN EACH OF THE HHES AND M0.46 GROUPS, NONE IN THE M0.44 AND M0.8 GROUPS, AND 3 OF 14 PROCEDURES IN M0.37 GROUP. NO FURTHER ADVERSE EVENTS DURING THE APHERESIS PROCEDURE WERE RECORDED. 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 THAT 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 "EFFICIENT GRANULOCYTE COLLECTION METHOD USING HIGH CONCENTRATIONS OF MEDIUM MOLECULAR WEIGHT HYDROXYETHYL STARCH." BY KONDO ET. AL CITRATE REACTIONS DURING GRANULOCYTE APHERESIS WERE RECORDED IN 1 OF 8 PROCEDURES IN EACH OF THE HHES AND M0.46 GROUPS, NONE IN THE M0.44 AND M0.8 GROUPS, AND 3 OF 14 PROCEDURES IN M0.37 GROUP. NO FURTHER ADVERSE EVENTS DURING THE APHERESIS PROCEDURE WERE RECORDED. 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 THAT 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 "EFFICIENT GRANULOCYTE COLLECTION METHOD USING HIGH CONCENTRATIONS OF MEDIUM MOLECULAR WEIGHT HYDROXYETHYL STARCH." BY KONDO ET. AL CITRATE REACTIONS DURING GRANULOCYTE APHERESIS WERE RECORDED IN 1 OF 8 PROCEDURES IN EACH OF THE HHES AND M0.46 GROUPS, NONE IN THE M0.44 AND M0.8 GROUPS, AND 3 OF 14 PROCEDURES IN M0.37 GROUP. NO FURTHER ADVERSE EVENTS DURING THE APHERESIS PROCEDURE WERE RECORDED. 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 THAT 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 |
|---|---|---|---|---|---|---|---|
| 2209648 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 10220 | NOT PROVIDED | 05020583102200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |