SPECTRA OPTIA
Report
- Report Number
- 1722028-2023-00156
- Event Type
- Injury
- Date Received
- April 25, 2023
- Date of Event
- March 19, 2023
- Report Date
- April 25, 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
INVESTIGATION: THE PURPOSE OF THE JOURNAL ARTICLE STUDY IS NOTED IN THE ARTICLE ABSTRACT: SINCE 2020, THE NOVEL CORONAVIRUS INFECTION (COVID-19) HAS SPREAD GLOBALLY. A FEW STUDIES HAVE INVESTIGATED THE SAFETY OF COVID-19 CONVALESCENT PLASMA (CCP) APHERESIS FROM COVID-19. THIS STUDY WAS THE FIRST RETROSPECTIVE OBSERVATIONAL STUDY OF CCP IN JAPAN. WE RECRUIT DONORS JOURNAL PRE-PROOF 2 FROM APRIL 2020 TO NOVEMBER 2021 AND PLASMAPHERESIS IN OUR CENTER (NCGM: NATIONAL CENTER FOR GLOBAL HEALTH AND MEDICINE). WE SET THE PRIMARY ENDPOINT AS THE DONORS ADVERSE EVENT (DAE) OCCURRENCE AT THE TIME OF THE CCP COLLECTION. VARIABLE SELECTION WAS USED TO EXPLORE THE DETERMINANTS OF DAE. MEAN AND SD AGE WAS 50.5 (10.6) YEARS OLD. SEVENTY-THREE (42.2%) WERE FEMALE, AND 87 (33.3%) WERE MULTIPLE-TIMES DONORS. TWELVE (6.97% BY DONORS AND 4.6% IN TOTAL COLLECTIONS) ADVERSE EVENTS OCCURRED. THE DAES WERE VVR (VASO VAGAL REACTION), PARESTHESIA, HYPOTENSION, AGITATION, DIZZINESS, MALAISE, AND HEARING IMPAIRMENT/PARESTHESIA. HALF OF THEM WERE VVR DURING APHERESIS. DAE OCCURRED ONLY IN FIRST-TIME DONORS AND MORE IN SEVERE ILLNESSES SUCH AS USING VENTILATION AND ECMO. FROM THE DONOR CHARACTERISTICS AND VARIABLE SELECTION, THE RISK FACTORS ARE AS FOLLOWS: YOUNGER AGE, FEMALE, THE SEVERITY OF DISEASE AT THE TIME OF THE DISEASE, AND LOWER SBP BEFORE INITIATION. OUR DAE INCIDENCE DID NOT DIFFER FROM PREVIOUS STUDIES. DAES WERE MORE LIKELY TO OCCUR IN CCP APHERESIS THAN IN HEALTHY DONORS. WE CONFIRM THE SAFETY OF CCP APHERESIS IN THIS STUDY, ALTHOUGH DAES WERE MORE THAN HEALTHY DONORS. MORE CAUTION SHOULD BE EXERCISED IN THE PLASMA COLLECTION FOR FUTURE OUTBREAKS OF EMERGING INFECTIOUS DISEASES. REGARDING TERUMO BCT PRODUCT, THE AUTHORS REPORTED THAT CCP COLLECTION WAS PERFORMED UNDER THE OBSERVATION OF A PHYSICIAN, A NURSE, AND A CLINICAL ENGINEER. WE USED THE PLASMA COMPONENT SEPARATOR (SPECTRA OPTIA® BY TERUMO BCT OR COM.TEC® BY FRESENIUS KABI) BASED ON THE DONORS¿ VESSEL CONDITION. THE PHYSICIAN RECHECKED THE CRITERIA AND OBTAINED INFORMED CONSENT BEFORE CCP COLLECTION. THE QUALIFIED PARTICIPANTS WERE THEN ADMINISTERED 400 MG OF CALCIUM GLUCONATE TO PREVENT HYPOCALCEMIA AND WERE ALSO RECOMMENDED TO TAKE FLUIDS. THE VOLUME OF PLASMA COLLECTED WAS 300¿600 ML [10] (SUPPLEMENTAL DATA 1), WHICH WAS APPROXIMATELY 25% OF THE EXTRACORPOREAL CIRCULATING BLOOD VOLUME. WE CHECKED THE AGGRAVATING SYMPTOMS AND THE VITAL SIGNS (BLOOD PRESSURE, HEART RATE, AND SPO2) AND MONITORED THE ELECTROCARDIOGRAM (ECG) EVERY 10 MINUTES DURING THE APHERESIS. WE TOOK THE UTMOST CARE TO MAKE THE APHERESIS AS RELAXING AS POSSIBLE. AFTER COMPLETING THE APHERESIS, THE DONORS WERE MONITORED FOR 30 MINUTES AND RETURNED HOME AFTER CONFIRMATION THAT THERE WAS NO CHANGE IN THEIR PHYSICAL CONDITION. ANY PARTICIPANT WITH A CHANGE IN THEIR PHYSICAL CONDITION WAS CALLED IN AND RECORDED AS A DAE. TWO TYPES OF APHERESIS MACHINES WERE USED: 48 DONORS USED THE SPECTRA OPTIA (17.7%) AND 125 DONORS USED THE COM.TEC (72.3%). THE FREQUENCY OF DAES WAS HIGHER IN THE SPECTRA OPTIA GROUP, THOUGH INSIGNIFICANT. THE NUMBER OF GRADE 2 DAES WAS SIGNIFICANTLY HIGHER IN THE SPECTRA OPTIA GROUP THAN IN THE COM.TEC GROUP. THERE WERE 12 ADVERSE REACTIONS, FOUR OCCURRED DURING AND EIGHT AFTER APHERESIS. HALF OF THE DAES WERE VASOVAGAL REACTIONS (VVR) WITH OR WITHOUT A DECREASE IN BLOOD PRESSURE DURING APHERESIS. VVR WAS ALSO SEEN IN THREE CASES AFTER APHERESIS. ALTHOUGH THREE OF SIX DONORS WITH VVR NEEDED AN INFUSION OF SALINE, ALL PARTICIPANTS RAPIDLY RECOVERED. THE OTHER CASES OF DAES WERE GRADE 1 SSCRBD [11] AND CTCAE 5.0 [13] CRITERIA, EXCEPT FOR THREE REPLENISHMENT CASES. MILD DAES WERE PARESTHESIA DURING APHERESIS, TWO INCIDENCES OF MALAISE, AND ONE EACH OF AGITATION, DIZZINESS, AND HEARING IMPAIRMENT/PARESTHESIA AFTER APHERESIS. ALL THE DAES IMPROVED WITHIN HOURS FROM ONSET. OVERALL, AUTHORS CONCLUDED THIS STUDY IS THE FIRST TO REPORT CONVALESCENT PLASMA COLLECTION IN JAPAN. WE EVALUATED THE SAFETY OF PLASMA COLLECTION FROM DONORS WHO HAD RECOVERED FROM COVID-19. THE INCIDENCE OF DAES WAS 6.94% WHICH WAS SIGNIFICANTLY HIGHER IN DONORS WITH SEVERE DISEASE THAN IN HEALTHY DONORS. HOWEVER, WE CONFIRM THE SAFETY AND CHARACTERISTICS OF DAES DURING CCP APHERESIS. IT IS NECESSARY TO PREPARE FOR FUTURE OUTBREAKS OF EMERGING INFECTIOUS DISEASES. A RISK ASSESSMENT WAS CONDUCTED FOR THIS FAILURE. 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. VASOVAGAL INCIDENTS OCCUR AROUND 0.5% OF PROCEDURES. THE REACTIONS GENERALLY MANIFEST AS PALLOR AND DIAPHORESIS. IN A FULL BLOWN ATTACK, THE REACTION PROGRESSES FROM PALLOR AND SWEATING TO PULSE SLOWING AND BLOOD PRESSURE DECREASING. MORE SEVERE VASOVAGAL REACTIONS MAY INCLUDE NAUSEA, VOMITING, AND/OR CONVULSIONS. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARASETHESIA (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. SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS THE SAFETY OF PLASMA APHERESIS FROM DONORS RECOVERING FROM COVID-19 INFECTION IN JAPAN FROM APRIL 2020 TO NOVEMBER 2021, 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. ROOT CAUSE: BASED ON THE AVAILABLE INFORMATION WITHIN THE JOURNAL ARTICLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED HYPOTENSION IS A COMMON SIDE EFFECT OF THERAPEUTIC APHERESIS PROCEDURES. IT IS TYPICALLY CAUSED BY FLUID SHIFT, BLOOD LOSS, LENGTH OF THE PROCEDURE, DONOR¿S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. PARESTHESIA IS A SYMPTOM OF HYPOCALCEMIA AND MAY 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. ARTICLE CITATION: AYUMI KAMO-IMAI, TOMITERU TOGANO, MOTOHIKO SATO, YUIKO KAWAKAMI, KUMI INABA, HIROSHI SHIMAZU, SAORI IGARASHI, KEIKO TANAKA, MARI TERADA, NORIKO KINOSHITA-IWAMOTO, SHO SAITO, SATOSHI KUTSUNA, AKIRA HANGAISHI, SHINICHIRO MORIOKA, KENZO TAKAHASHI, SATOSHI MIYATA AND NORIO OHMAGARI, THE SAFETY OF PLASMA APHERESIS FROM DONORS RECOVERING FROM COVID19 INFECTION IN JAPAN, TRANSFUSION AND APHERESIS SCIENCE, (2023) DOI:HTTPS://DOI.ORG/10.1016/J.TRANSCI.2023.103687.
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. ARTICLE CITATION: AYUMI KAMO-IMAI, TOMITERU TOGANO, MOTOHIKO SATO, YUIKO KAWAKAMI, KUMI INABA, HIROSHI SHIMAZU, SAORI IGARASHI, KEIKO TANAKA, MARI TERADA, NORIKO KINOSHITA-IWAMOTO, SHO SAITO, SATOSHI KUTSUNA, AKIRA HANGAISHI, SHINICHIRO MORIOKA, KENZO TAKAHASHI, SATOSHI MIYATA AND NORIO OHMAGARI, THE SAFETY OF PLASMA APHERESIS FROM DONORS RECOVERING FROM COVID19 INFECTION IN JAPAN, TRANSFUSION AND APHERESIS SCIENCE, (2023) DOI:HTTPS://DOI.ORG/10.1016/J.TRANSCI.2023.103687.
PER THE JOURNAL ARTICLE: THE SAFETY OF PLASMA APHERESIS FROM DONORS RECOVERING FROM COVID-19 INFECTION IN JAPAN. TRANSFUSION AND APHERESIS SCIENCE. 2023. BY KAMO-IMAI, AYUMI, TOGANO, TOMITERU,SATO, MOTOHIKO,KAWAKAMI, ET AL. "WE USED TWO TYPES OF APHERESIS MACHINES: 48 DONORS USED THE SPECTRA OPTIA (17.7%) AND 125 DONORS USED THE COM.TEC (72.3%). THE FREQUENCY OF DAES WAS HIGHER IN THE SPECTRA OPTIA GROUP, THOUGH INSIGNIFICANT. THE NUMBER OF GRADE 2 DAES WAS SIGNIFICANTLY HIGHER IN THE SPECTRA OPTIA GROUP THAN IN THE COM.TEC GROUP. THERE WERE 12 ADVERSE REACTIONS, FOUR OCCURRED DURING AND EIGHT AFTER APHERESIS. HALF OF THE DAES WERE VASOVAGAL REACTIONS (VVR) WITH OR WITHOUT A DECREASE IN BLOOD PRESSURE DURING APHERESIS. VVR WAS ALSO SEEN IN THREE CASES AFTER APHERESIS. ALTHOUGH THREE OF SIX DONORS WITH VVR NEEDED AN INFUSION OF SALINE, ALL PARTICIPANTS RAPIDLY RECOVERED. THE OTHER CASES OF DAES WERE GRADE 1 SSCRBD [11] AND CTCAE 5.0 [13] CRITERIA, EXCEPT FOR THREE REPLENISHMENT CASES. MILD DAES WERE PARESTHESIA DURING APHERESIS, TWO INCIDENCES OF MALAISE, AND ONE EACH OF AGITATION, DIZZINESS, AND HEARING IMPAIRMENT/PARESTHESIA AFTER APHERESIS. ALL THE DAES IMPROVED WITHIN HOURS FROM ONSET. " PER THE ARTICLE, THREE OF THE SIX VASOVAGAL REACTIONS REQUIRED AN INFUSION OF SALINE. ALL OTHER ADVERSE EVENTS IMPROVED WITHIN HOURS OF ONSET. ALL PATIENTS WERE LISTED AS IMPROVED AT THE END OF THE STUDY. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO AN ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.
PER THE JOURNAL ARTICLE: THE SAFETY OF PLASMA APHERESIS FROM DONORS RECOVERING FROM COVID-19 INFECTION IN JAPAN. TRANSFUSION AND APHERESIS SCIENCE. 2023. BY KAMO-IMAI, AYUMI, TOGANO, TOMITERU,SATO, MOTOHIKO,KAWAKAMI, ET AL. "WE USED TWO TYPES OF APHERESIS MACHINES: 48 DONORS USED THE SPECTRA OPTIA (17.7%) AND 125 DONORS USED THE COM.TEC (72.3%). THE FREQUENCY OF DAES WAS HIGHER IN THE SPECTRA OPTIA GROUP, THOUGH INSIGNIFICANT. THE NUMBER OF GRADE 2 DAES WAS SIGNIFICANTLY HIGHER IN THE SPECTRA OPTIA GROUP THAN IN THE COM.TEC GROUP.... THERE WERE 12 ADVERSE REACTIONS, FOUR OCCURRED DURING AND EIGHT AFTER APHERESIS. HALF OF THE DAES WERE VASOVAGAL REACTIONS (VVR) WITH OR WITHOUT A DECREASE IN BLOOD PRESSURE DURING APHERESIS. VVR WAS ALSO SEEN IN THREE CASES AFTER APHERESIS. ALTHOUGH THREE OF SIX DONORS WITH VVR NEEDED AN INFUSION OF SALINE, ALL PARTICIPANTS RAPIDLY RECOVERED. THE OTHER CASES OF DAES WERE GRADE 1 SSCRBD [11] AND CTCAE 5.0 [13] CRITERIA, EXCEPT FOR THREE REPLENISHMENT CASES. MILD DAES WERE PARESTHESIA DURING APHERESIS, TWO INCIDENCES OF MALAISE, AND ONE EACH OF AGITATION, DIZZINESS, AND HEARING IMPAIRMENT/PARESTHESIA AFTER APHERESIS. ALL THE DAES IMPROVED WITHIN HOURS FROM ONSET. " PER THE ARTICLE, THREE OF THE SIX VASOVAGAL REACTIONS REQUIRED AN INFUSION OF SALINE. ALL OTHER ADVERSE EVENTS IMPROVED WITHIN HOURS OF ONSET. ALL PATIENTS WERE LISTED AS IMPROVED AT THE END OF THE STUDY. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539680 | SPECTRA OPTIA | SPECTRA OPTIA PLATELET PLASMA SET | LKN | TERUMO BCT | 10220 | 05020583102200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |