SPECTRA OPTIA
Report
- Report Number
- 1722028-2024-00266
- Event Type
- Injury
- Date Received
- June 20, 2024
- Date of Event
- June 20, 2020
- Report Date
- June 20, 2024
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583102200
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5, B.7, H.6 AND H.11. INVESTIGATION: TO EVALUATE THE THERAPEUTIC USE OF PLASMA EXCHANGE IN COVID-19 PATIENTS COMPARED TO CONTROLS. METHODS: A CASE SERIES OF CRITICALLY ILL ADULT MEN AND NON-PREGNANT WOMEN, > 18 YEARS OF AGE, LABORATORY-CONFIRMED COVID-19, WAS STUDIED AT THE (B)(6) HOSPITAL, (B)(6), FROM (B)(6) 2020. THERAPEUTIC PLASMA EXCHANGE (TPE) WAS PERFORMED ON PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH CONFIRMED OR IMMINENT ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR SEVERE PNEUMONIA. THE ANALYSIS WAS PERFORMED USING UNIVARIATE STATISTICS. RESULTS: A TOTAL OF (B)(4) COVID-19 PATIENTS WERE INCLUDED WITH AN OVERALL MEAN AGE OF 51 + 15 YEARS (RANGE: 27¿76 YEARS); (B)(4) (N = 28) WERE MALES, AND (B)(4) (N = 11) OF THE PATIENTS HAD TPE AS A MODE OF TREATMENT. THE TPE GROUP WAS ASSOCIATED WITH HIGHER EXTUBATION RATES THAN THE NON-TPE COHORT ((B)(4); P = 0.018). ADDITIONALLY, PATIENTS ON TPE HAD A LOWER 14 DAYS ((B)(4); P = 0.033) AND 28 DAYS ((B)(4); P = 0.033) POST PLASMA EXCHANGE MORTALITY COMPARED TO PATIENTS NOT ON TPE. HOWEVER, ALL-CAUSE MORTALITY WAS ONLY MARGINALLY LOWER IN THE TPE GROUP COMPARED TO THE NON-TPE GROUP ((B)(4); P = 0.055; POWER = (B)(4)). LABORATORY AND VENTILATORY PARAMETERS ALSO IMPROVED POST TPE (N = 11). CONCLUSIONS: THE USE OF TPE IN SEVERE COVID-19 PATIENTS HAS BEEN ASSOCIATED WITH IMPROVED OUTCOMES, HOWEVER, RANDOMIZED CONTROLLED CLINICAL TRIALS ARE WARRANTED TO DRAW FINAL, CONCLUSIVE FINDINGS. TPE WAS PERFORMED USING THE SPECTRA OPTIA1APHERESIS SYSTEM ((B)(6), JAPAN), A STANDARD PLASMA EXCHANGE KIT (CATALOG NUMBER: 502058310220), WITH CITRATE DEXTROSE SOLUTION, SOLUTION A (ACD-A) USED AS AN ANTICOAGULANT. FRESH FROZEN PLASMA (FFP) WAS USED AS A REPLACEMENT SOLUTION. THE TOTAL VOLUME OF PLASMA TO BE REPLACED WAS CALCULATED AS FOLLOWS: PLASMA REPLACEMENT (L) = BODY WEIGHT (KG) X (1/13) X (100-HEMATOCRIT). TPE WAS PERFORMED THROUGH A STANDARD FEMORAL CENTRAL VENOUS CATHETER (12 FR). EACH PATIENT UNDERWENT A TOTAL OF FIVE PROCEDURES. THIS STUDY ENROLLED A TOTAL OF (B)(4) COVID-19 PATIENTS WITH LABORATORY CONFIRMED SARS-COV-2 INFECTION WITH AN OVERALL MEAN AGE OF 51 + 15 YEARS (RANGE: 27¿76 YEARS) AND 90% (N = 28) WERE MALES. A TOTAL OF (B)(4) (N = 11) OF THE PATIENTS HAD TPE AS A TREATMENT MODE. THE THREE MOST PREVALENT COMORBIDITIES WERE DIABETES MELLITUS ((B)(4); N = 15), HYPERTENSION ((B)(4); N = 12) AND CHRONIC KIDNEY DISEASE ((B)(4); N = 4). BOTH THE TPE AND THE CONTROL GROUPS HAD SIMILAR BASELINE CHARACTERISTICS AND UNDERLYING CO-MORBIDITIES. THE OVERALL MEDIAN SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA) SCORE WAS 3 (2¿6) FOR THE CONTROL GROUP AND 6 (3-9) FOR THE TPE GROUP. (B)(4) PERCENT (N = 10) OF THE PATIENTS IN THE TPE GROUP HAD EITHER MODERATE [PAO2/FIO2 ¿ 200¿100] OR SEVERE ARDS [PAO2 / FIO2 100-200], WHILE (B)(4) (N = 10) IN THE CONTROL HAD EITHER MODERATE OR SEVERE ARDS. A TOTAL OF (B)(4) (N = 10) OF THE PATIENTS IN THE CONTROL GROUP PRESENTED WITH SEVERE PNEUMONIA. (B)(4) PERCENT (N = 19) OF THE PATIENTS HAD SEPTIC SHOCK, (B)(4) (N = 9) IN TPE GROUP AND (B)(4) (N = 10) IN THE CONTROL GROUP, AND (B)(4) (N = 4) HAD MOD, (B)(4) (N = 1) IN THE TPE GROUP AND (B)(4) (N = 3) IN THE CONTROL GROUP, RESPECTIVELY. THERE WAS A TREND FOR THOSE IN THE TPE GROUP TO HAVE WORSE SOFA SCORES AND ARDS, HOWEVER, THE P-VALUES WERE NOT STATISTICALLY SIGNIFICANT. THOSE ON PLASMA EXCHANGE WERE LESS LIKELY TO BE DIAGNOSED WITH SEVERE PNEUMONIA THAN THOSE NOT ON PLASMA EXCHANGE ((B)(4) VERSUS (B)(4); P = 0.047). TABLE 1 TABLE 2 OUTLINES THE CLINICAL OUTCOME CHARACTERISTICS OF THE COHORT STRATIFIED BY TPE. THOSE ON PLASMA EXCHANGE WERE ASSOCIATED WITH LONGER ICU LENGTH OF STAY THAN THOSE THAT WERE NOT ON PLASMA EXCHANGE (14 VERSUS 6 DAYS; P = 0.028), AS THEY WERE MORE SERIOUSLY ILL. ADDITIONALLY, THOSE ON TPE WERE ALSO MORE LIKELY TO BE EXTUBATED THAN THOSE NOT ON PLASMA EXCHANGE ((B)(4) VERSUS 20%; P = 0.018). FURTHERMORE, PATIENTS ON TPE HAD A LOWER 14 DAYS ((B)(4); P = 0.033) AND 28 DAYS ((B)(4); P = 0.033) MORTALITY COMPARED TO PATIENTS NOT ON TPE. HOWEVER, ALL-CAUSE MORTALITY WAS ONLY MARGINALLY LOWER IN THE PLASMA EXCHANGE GROUP THAN THOSE NOT ON PLASMA EXCHANGE ((B)(4); P = 0.055; POWER = (B)(4)). CLINICAL INDEXES, LABORATORY FINDINGS, AND VENTILATORY PARAMETERS BEFORE AND AFTER PLASMA EXCHANGE ARE PRESENTED IN TABLE 3. THOSE ON TPE GENERALLY SHOWED REDUCTIONS IN SOFA SCORES, IL-6, CRP, D-DIMER, AND FERRITIN LEVELS. IT IS ALSO NECESSARY TO ADMINISTER TPE FOR THE CORRECT DURATION AND VOLUME, TO MONITOR THE POTENTIAL DRUG REMOVAL OF SPECIFIC THERAPIES SUCH AS IMMUNOMODULATING AGENTS AND TO PRACTICE THE PROPER INFECTION PREVENTION AND CONTROL MEASURES. TPE IS A TOLERABLE PROCEDURE BY MOST PATIENTS WITHOUT ADVERSE EVENTS; HOWEVER, THE PROCEDURE CAN BE A CHALLENGE TO PERFORM IN COVID-19 PATIENTS WHO ARE PLACED IN A PRONE POSITION. EARLIER STUDIES OF THE USE OF PLASMA EXCHANGE IN SEPSIS HAVE SHOWN THAT BOTH THE TIMING AND DISEASE SEVERITY ARE IMPORTANT FOR THE BENEFICIAL EFFECT OF TPE (YANG ET AL., 2020). WE ROUTINELY PERFORMED FIVE TPES DAILY AND NOTED THAT RESPIRATORY IMPROVEMENTS WERE ONLY SEEN AFTER COMPLETING THE THERAPY ON DAY 7. RECOGNIZED ADVERSE EVENTS RELATED TO TPE INCLUDE ALLERGIC REACTIONS, HYPOTENSION, HYPOCALCEMIA, AND LINE-RELATED INFECTIONS. ALL PATIENTS IN THIS CASE STUDY TOLERATED TPE EXCEPT FOR ONE HYPOTENSION EPISODE, WHICH RESOLVED AFTER NORMAL SALINE BOLUS AND HYDROCORTISONE INJECTION AND DID NOT RECUR WITH SUBSEQUENT PROCEDURES. SINCE THIS WAS A JOURNAL PUBLICATION TO EVALUATE THE THERAPEUTIC USE OF PLASMA EXCHANGE IN COVID-19 PATIENTS COMPARED TO CONTROLS, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF (B)(4). SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. SINCE THIS WAS A JOURNAL PUBLICATION TO EVALUATE THE THERAPEUTIC USE OF PLASMA EXCHANGE IN COVID-19 PATIENTS COMPARED TO CONTROLS, THE LOT NUMBERS WERE NOT REQUESTED, 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: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE REPORTED HYPOTENSION. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. VASOVAGAL ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE LENGTH OF THE PROCEDURE, THE PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR THE HEMODYNAMIC STRESS OF THE PROCEDURE. CITATION: KHAMIS, F., AL-ZAKWANI, I., HASHMI, S. A., DOWAIKI, S. A., BAHRANI, M. A., PANDAK, N., KHALILI, H. A., & MEMISH, Z. (2020). THERAPEUTIC PLASMA EXCHANGE IN ADULTS WITH SEVERE COVID-19 INFECTION. INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, 99, 214¿218. HTTPS://DOI.ORG/10.1016/J.IJID.2020.06.064.
LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: KHAMIS, F., AL-ZAKWANI, I., HASHMI, S. A., DOWAIKI, S. A., BAHRANI, M. A., PANDAK, N., KHALILI, H. A., & MEMISH, Z. (2020). THERAPEUTIC PLASMA EXCHANGE IN ADULTS WITH SEVERE COVID-19 INFECTION. INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, 99, 214¿218. HTTPS://DOI.ORG/10.1016/J.IJID.2020.06.064.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: TO EVALUATE THE THERAPEUTIC USE OF PLASMA EXCHANGE IN COVID-19 PATIENTS COMPARED TO CONTROLS. METHODS: A CASE SERIES OF CRITICALLY ILL ADULT MEN AND NON-PREGNANT WOMEN, 18 YEARS OF AGE, LABORATORY-CONFIRMED COVID-19, WAS STUDIED AT THE (B)(6) HOSPITAL, (B)(6), FROM (B)(6) 2020. THERAPEUTIC PLASMA EXCHANGE (TPE) WAS PERFORMED ON PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH CONFIRMED OR IMMINENT ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR SEVERE PNEUMONIA. THE ANALYSIS WAS PERFORMED USING UNIVARIATE STATISTICS. RESULTS: A TOTAL OF (B)(4) COVID-19 PATIENTS WERE INCLUDED WITH AN OVERALL MEAN AGE OF 51 + 15 YEARS (RANGE: 27-76 YEARS); (B)(4) WERE MALES, AND (B)(4) OF THE PATIENTS HAD TPE AS A MODE OF TREATMENT. THE TPE GROUP WAS ASSOCIATED WITH HIGHER EXTUBATION RATES THAN THE NON-TPE COHORT ((B)(4)). ADDITIONALLY, PATIENTS ON TPE HAD A LOWER 14 DAYS ((B)(4)) AND 28 DAYS ((B)(4)) POST PLASMA EXCHANGE MORTALITY COMPARED TO PATIENTS NOT ON TPE. HOWEVER, ALL-CAUSE MORTALITY WAS ONLY MARGINALLY LOWER IN THE TPE GROUP COMPARED TO THE NON-TPE GROUP ((B)(4)). LABORATORY AND VENTILATORY PARAMETERS ALSO IMPROVED POST TPE ((B)(4)). CONCLUSIONS: THE USE OF TPE IN SEVERE COVID-19 PATIENTS HAS BEEN ASSOCIATED WITH IMPROVED OUTCOMES, HOWEVER, RANDOMIZED CONTROLLED CLINICAL TRIALS ARE WARRANTED TO DRAW FINAL, CONCLUSIVE FINDINGS. TPE WAS PERFORMED USING THE SPECTRA OPTIA1APHERESIS SYSTEM ((B)(6), JAPAN), A STANDARD PLASMA EXCHANGE KIT (CATALOG NUMBER: 502058310220), WITH CITRATE DEXTROSE SOLUTION, SOLUTION A (ACD-A) USED AS AN ANTICOAGULANT. FRESH FROZEN PLASMA (FFP) WAS USED AS A REPLACEMENT SOLUTION. THE TOTAL VOLUME OF PLASMA TO BE REPLACED WAS CALCULATED AS FOLLOWS: PLASMA REPLACEMENT (L) = BODY WEIGHT (KG) X (1/13) X (100-HEMATOCRIT). TPE WAS PERFORMED THROUGH A STANDARD FEMORAL CENTRAL VENOUS CATHETER (12 FR). EACH PATIENT UNDERWENT A TOTAL OF (B)(4) PROCEDURES. THIS STUDY ENROLLED A TOTAL OF (B)(4) COVID-19 PATIENTS WITH LABORATORY CONFIRMED SARS-COV-2 INFECTION WITH AN OVERALL MEAN AGE OF 51 + 15 YEARS (RANGE: 27-76 YEARS) AND (B)(4) WERE MALES. A TOTAL OF (B)(4) OF THE PATIENTS HAD TPE AS A TREATMENT MODE. THE THREE MOST PREVALENT COMORBIDITIES WERE DIABETES MELLITUS ((B)(4)), HYPERTENSION ((B)(4)) AND CHRONIC KIDNEY DISEASE ((B)(4)). BOTH THE TPE AND THE CONTROL GROUPS HAD SIMILAR BASELINE CHARACTERISTICS AND UNDERLYING CO-MORBIDITIES. THE OVERALL MEDIAN SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA) SCORE WAS 3 (2-6) FOR THE CONTROL GROUP AND 6 (3-9) FOR THE TPE GROUP. (B)(4) OF THE PATIENTS IN THE TPE GROUP HAD EITHER MODERATE [PAO2/FIO2 200-100] OR SEVERE ARDS [PAO2 / FIO2 100-200], WHILE (B)(4)) IN THE CONTROL HAD EITHER MODERATE OR SEVERE ARDS. A TOTAL OF (B)(4) OF THE PATIENTS IN THE CONTROL GROUP PRESENTED WITH SEVERE PNEUMONIA. (B)(4) OF THE PATIENTS HAD SEPTIC SHOCK, (B)(4) IN TPE GROUP AND (B)(4) IN THE CONTROL GROUP, AND (B)(4) HAD MOD, (B)(4)) IN THE TPE GROUP AND (B)(4)) IN THE CONTROL GROUP, RESPECTIVELY. THERE WAS A TREND FOR THOSE IN THE TPE GROUP TO HAVE WORSE SOFA SCORES AND ARDS, HOWEVER, THE P-VALUES WERE NOT STATISTICALLY SIGNIFICANT. THOSE ON PLASMA EXCHANGE WERE LESS LIKELY TO BE DIAGNOSED WITH SEVERE PNEUMONIA THAN THOSE NOT ON PLASMA EXCHANGE ((B)(4)). TABLE 1 TABLE 2 OUTLINES THE CLINICAL OUTCOME CHARACTERISTICS OF THE COHORT STRATIFIED BY TPE. THOSE ON PLASMA EXCHANGE WERE ASSOCIATED WITH LONGER ICU LENGTH OF STAY THAN THOSE THAT WERE NOT ON PLASMA EXCHANGE ((B)(4)), AS THEY WERE MORE SERIOUSLY ILL. ADDITIONALLY, THOSE ON TPE WERE ALSO MORE LIKELY TO BE EXTUBATED THAN THOSE NOT ON PLASMA EXCHANGE ((B)(4)). FURTHERMORE, PATIENTS ON TPE HAD A LOWER 14 DAYS ((B)(4)) AND 28 DAYS ((B)(4)) MORTALITY COMPARED TO PATIENTS NOT ON TPE. HOWEVER, ALL-CAUSE MORTALITY WAS ONLY MARGINALLY LOWER IN THE PLASMA EXCHANGE GROUP THAN THOSE NOT ON PLASMA EXCHANGE ((B)(4)). CLINICAL INDEXES, LABORATORY FINDINGS, AND VENTILATORY PARAMETERS BEFORE AND AFTER PLASMA EXCHANGE ARE PRESENTED IN TABLE 3. THOSE ON TPE GENERALLY SHOWED REDUCTIONS IN SOFA SCORES, IL-6, CRP, D-DIMER, AND FERRITIN LEVELS. IT IS ALSO NECESSARY TO ADMINISTER TPE FOR THE CORRECT DURATION AND VOLUME, TO MONITOR THE POTENTIAL DRUG REMOVAL OF SPECIFIC THERAPIES SUCH AS IMMUNOMODULATING AGENTS AND TO PRACTICE THE PROPER INFECTION PREVENTION AND CONTROL MEASURES. TPE IS A TOLERABLE PROCEDURE BY MOST PATIENTS WITHOUT ADVERSE EVENTS; HOWEVER, THE PROCEDURE CAN BE A CHALLENGE TO PERFORM IN COVID-19 PATIENTS WHO ARE PLACED IN A PRONE POSITION. EARLIER STUDIES OF THE USE OF PLASMA EXCHANGE IN SEPSIS HAVE SHOWN THAT BOTH THE TIMING AND DISEASE SEVERITY ARE IMPORTANT FOR THE BENEFICIAL EFFECT OF TPE (YANG ET AL., 2020). WE ROUTINELY PERFORMED FIVE TPES DAILY AND NOTED THAT RESPIRATORY IMPROVEMENTS WERE ONLY SEEN AFTER COMPLETING THE THERAPY ON DAY 7. RECOGNIZED ADVERSE EVENTS RELATED TO TPE INCLUDE ALLERGIC REACTIONS, HYPOTENSION, HYPOCALCEMIA, AND LINE-RELATED INFECTIONS. ALL PATIENTS IN THIS CASE STUDY TOLERATED TPE EXCEPT FOR ONE HYPOTENSION EPISODE, WHICH RESOLVED AFTER NORMAL SALINE BOLUS AND HYDROCORTISONE INJECTION AND DID NOT RECUR WITH SUBSEQUENT PROCEDURES. SINCE THIS WAS A JOURNAL PUBLICATION TO EVALUATE THE THERAPEUTIC USE OF PLASMA EXCHANGE IN COVID-19 PATIENTS COMPARED TO CONTROLS, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF (B)(4). SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. SINCE THIS WAS A JOURNAL PUBLICATION TO EVALUATE THE THERAPEUTIC USE OF PLASMA EXCHANGE IN COVID-19 PATIENTS COMPARED TO CONTROLS, THE LOT NUMBERS WERE NOT REQUESTED, 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. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: KHAMIS, F., AL-ZAKWANI, I., HASHMI, S. A., DOWAIKI, S. A., BAHRANI, M. A., PANDAK, N., KHALILI, H. A., & MEMISH, Z. (2020). THERAPEUTIC PLASMA EXCHANGE IN ADULTS WITH SEVERE COVID-19 INFECTION. INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, 99, 214-218. HTTPS://DOI.ORG/10.1016/J.IJID.2020.06.064.
PER JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN ADULTS WITH SEVERE COVID-19 INFECTION" BY KHAMIS, F., AL-ZAKWANI, I., AL HASHMI, S., AL DOWAIKI, S., AL BAHRANI, M., PANDAK, N., AL KHALILI, H., MEMISH, Z.. ALL PATIENTS IN THIS CASE STUDY TOLERATED TPE EXCEPT FOR ONE HYPOTENSION EPISODE, WHICH RESOLVED AFTER NORMAL SALINE BOLUS AND HYDROCORTISONE INJECTION AND DID NOT RECUR WITH SUBSEQUENT PROCEDURES. 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 PLASMA EXCHANGE IN ADULTS WITH SEVERE COVID-19 INFECTION" BY KHAMIS, F., AL-ZAKWANI, I., AL HASHMI, S., AL DOWAIKI, S., AL BAHRANI, M., PANDAK, N., AL KHALILI, H., MEMISH, Z.. ALL PATIENTS IN THIS CASE STUDY TOLERATED TPE EXCEPT FOR ONE HYPOTENSION EPISODE, WHICH RESOLVED AFTER NORMAL SALINE BOLUS AND HYDROCORTISONE INJECTION AND DID NOT RECUR WITH SUBSEQUENT PROCEDURES. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
PER JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN ADULTS WITH SEVERE COVID-19 INFECTION" BY KHAMIS, F., AL-ZAKWANI, I., AL HASHMI, S., AL DOWAIKI, S., AL BAHRANI, M., PANDAK, N., AL KHALILI, H., MEMISH, Z.. ALL PATIENTS IN THIS CASE STUDY TOLERATED TPE EXCEPT FOR ONE HYPOTENSION EPISODE, WHICH RESOLVED AFTER NORMAL SALINE BOLUS AND HYDROCORTISONE INJECTION AND DID NOT RECUR WITH SUBSEQUENT PROCEDURES. 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 |
|---|---|---|---|---|---|---|---|
| 2155827 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 05020583102200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |