Spectra Optia® 10220Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 05020583102200), received between Jan 23, 2019 and Jul 20, 2026 — classified as 4 deaths, 96 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (80 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Insufficient Device Problem Information

  PER JOURNAL ARTICLE "CENTRIFUGAL TECHNIQUE OF PLASMA EXCHANGE AND LOW-DOSE STEROID TO TREAT VERY SEVERE ALCOHOLIC HEPATITIS PATIENTS: A RETROSPECTIVE ANALYSIS" BY KUMAR, S. E., CHELLAIYA, G. K., SINGH, K. A., KARUPPUSAMI, R., DANIEL, D., DAVID, V. G., NAIR, S. C., VARUGHESE, S., MAMMEN, J., ELIAS, E., EAPEN, C. E., ZACHARIAH, U. G., & GOEL, A. BACKGROUNDLOW-VOLUME PLASMA EXCHANGE (PLEX) AND LOW-DOSE STEROID IMPROVE SURVIVAL IN SEVERE ALCOHOLIC HEPATITIS. WE AIMED TO COMPARE ONE-YEAR SURVIVAL OF VERY SEVERE ALCOHOLIC HEPATITIS (VSAH) PATIENTS TREATED WITH CENTRIFUGAL PLEX (CPLEX), MEMBRANE PLEX (MPLEX) OR STANDARD MEDICAL TREATMENT (SMT).METHODSWE RETROSPECTIVELY ANALYZED SURVIVAL IN CONSECUTIVE VSAH PATIENTS TREATED AT OUR DEPARTMENT FROM NOVEMBER 2017 TO SEPTEMBER 2021. PLEX PATIENTS RECEIVED LOW-VOLUME PLEX ALONG WITH LOW-DOSE STEROID (TAB. PREDNISOLONE 10 MG OR 20 MG DAILY). TO ADJUST FOR BASELINE DIFFERENCES BETWEEN THE THREE TREATMENT (CPLEX, MPLEX OR SMT) GROUPS, PROPENSITY SCORE (PS) MATCHING WAS DONE. ACUTE-ON-CHRONIC LIVER FAILURE (ACLF) WAS DEFINED AS PER EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER (EASL). THE PRIMARY STUDY OUTCOME WAS ONE-YEAR TRANSPLANT-FREE SURVIVA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25883689 ↗
• InjuryJul 13, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THE PATIENT DEVELOPED A SERIOUS REACTION AND HAD TO BE SHIFTED TO THE ICU FOR FURTHER MANAGEMENT. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804588 ↗
• InjuryJul 13, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THE PATIENT DEVELOPED A SERIOUS REACTION AND HAD TO BE SHIFTED TO THE ICU FOR FURTHER MANAGEMENT. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804444 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ""SCOPE AND SAFETY OF THERAPEUTIC PLASMA EXCHANGE BY CENTRIFUGATION IN PEDIATRIC PATIENTS: EXPERIENCE AT A TERTIARY CARE HOSPITAL IN WESTERN INDIA"" BY VIJAYKUMAR, S. C. (2025) ABSTRACT INTRODUCTION THERAPEUTIC PLASMA EXCHANGE (TPE) IS A WELL-KNOWN THERAPEUTIC MODALITY FOR TREATING VARIOUS PEDIATRIC DISEASES. HOWEVER, NO SPECIAL GUIDELINES ARE AVAILABLE FOR PEDIATRIC PATIENTS, AND ADULT GUIDELINES- AMERICAN SOCIETY FOR APHERESIS (ASFA) ARE OLLOWED.AIM: TO STUDY THE SAFETY OF TPE AND ANALYZE THE VARIOUS INDICATIONS FOR WHICH IT CAN BE DONE IN PEDIATRIC PATIENTS. MATERIAL AND METHODS: A 5-YEAR RETROSPECTIVE ANALYSIS OF THE INDICATIONS AND THEIR SAFETY WAS DONE FROM 2018 TO 2022.TPE WAS DONE BY CENTRIFUGATION RESULTS: TPE WAS PERFORMED IN 120 PATIENTS AND 926 PROCEDURES WERE DONE. ANTIBODY-MEDIATED REJECTION (ABMR) AND ATYPICAL HEMOLYTIC UREMIC SYNDROME (A HUS) WERE THE MOST COMMON INDICATIONS WITH 42.5% OF PROCEDURES EACH. PRE-RENAL TRANSPLANT DESENSITIZATION (8.3%) AND WILSONS DISEASE (2.5%) WERE OTHER INDICATIONS. THE MOST COMMON ADVERSE EVENT SEEN WAS MODERATE (53.57%), AND ALLERGIC REACTION TO REPLACEMENT FLUID -FRESH FROZEN PLASMA (FFP) WAS THE MOST COMMON. V

  Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction

  MAUDE report 23924203 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "SCOPE AND SAFETY OF THERAPEUTIC PLASMA EXCHANGE BY CENTRIFUGATION IN PEDIATRIC PATIENTS: EXPERIENCE AT A TERTIARY CARE HOSPITAL IN WESTERN INDIA" BY VIJAYKUMAR, S. C. (2025) ABSTRACT INTRODUCTION THERAPEUTIC PLASMA EXCHANGE (TPE) IS A WELL-KNOWN THERAPEUTIC MODALITY FOR TREATING VARIOUS PEDIATRIC DISEASES. HOWEVER, NO SPECIAL GUIDELINES ARE AVAILABLE FOR PEDIATRIC PATIENTS, AND ADULT GUIDELINES- AMERICAN SOCIETY FOR APHERESIS (ASFA) ARE OLLOWED.AIM: TO STUDY THE SAFETY OF TPE AND ANALYZE THE VARIOUS INDICATIONS FOR WHICH IT CAN BE DONE IN PEDIATRIC PATIENTS. MATERIAL AND METHODS: A 5-YEAR RETROSPECTIVE ANALYSIS OF THE INDICATIONS AND THEIR SAFETY WAS DONE FROM 2018 TO 2022.TPE WAS DONE BY CENTRIFUGATION RESULTS: TPE WAS PERFORMED IN 120 PATIENTS AND 926 PROCEDURES WERE DONE. ANTIBODY-MEDIATED REJECTION (ABMR) AND ATYPICAL HEMOLYTIC UREMIC SYNDROME (A HUS) WERE THE MOST COMMON INDICATIONS WITH (b)(4)% OF PROCEDURES EACH. PRE-RENAL TRANSPLANT DESENSITIZATION ((b)(4)%) AND WILSONS DISEASE (b)(4)%) WERE OTHER INDICATIONS. THE MOST COMMON ADVERSE EVENT SEEN WAS MODERATE (b)(4)%),AND ALLERGIC REACTION TO REPLACEMENT FLUID -FRESH FROZEN PLASMA (FFP) WAS THE MOST COMMO

  Patient problems: Convulsion/Seizure; Dyspnea; High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Loss of consciousness; Low Blood Pressure/ Hypotension; Rash; Vomiting

  MAUDE report 23924035 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ""SCOPE AND SAFETY OF THERAPEUTIC PLASMA EXCHANGE BY CENTRIFUGATION IN PEDIATRIC PATIENTS: EXPERIENCE AT A TERTIARY CARE HOSPITAL IN WESTERN INDIA"" BY VIJAYKUMAR, S. C. (2025) ABSTRACT INTRODUCTION THERAPEUTIC PLASMA EXCHANGE (TPE) IS A WELL-KNOWN THERAPEUTIC MODALITY FOR TREATING VARIOUS PEDIATRIC DISEASES. HOWEVER, NO SPECIAL GUIDELINES ARE AVAILABLE FOR PEDIATRIC PATIENTS, AND ADULT GUIDELINES- AMERICAN SOCIETY FOR APHERESIS (ASFA) ARE OLLOWED.AIM: TO STUDY THE SAFETY OF TPE AND ANALYZE THE VARIOUS INDICATIONS FOR WHICH IT CAN BE DONE IN PEDIATRIC PATIENTS. MATERIAL AND METHODS: A 5-YEAR RETROSPECTIVE ANALYSIS OF THE INDICATIONS AND THEIR SAFETY WAS DONE FROM 2018 TO 2022.TPE WAS DONE BY CENTRIFUGATION RESULTS: TPE WAS PERFORMED IN 120 PATIENTS AND 926 PROCEDURES WERE DONE. ANTIBODY-MEDIATED REJECTION (ABMR) AND ATYPICAL HEMOLYTIC UREMIC SYNDROME (A HUS) WERE THE MOST COMMON INDICATIONS WITH (b)(4) OF PROCEDURES EACH. PRE-RENAL TRANSPLANT DESENSITIZATION (8.3%) AND WILSONS DISEASE ((b)(4)) WERE OTHER INDICATIONS. THE MOST COMMON ADVERSE EVENT SEEN WAS MODERATE ((b)(4)),AND ALLERGIC REACTION TO REPLACEMENT FLUID -FRESH FROZEN PLASMA (FFP) WAS THE MOST COMMON.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23924032 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE ""SCOPE AND SAFETY OF THERAPEUTIC PLASMA EXCHANGE BY CENTRIFUGATION IN PEDIATRIC PATIENTS: EXPERIENCE AT A TERTIARY CARE HOSPITAL IN WESTERN INDIA"" BY VIJAYKUMAR, S. C. (2025) ABSTRACT INTRODUCTION THERAPEUTIC PLASMA EXCHANGE (TPE) IS A WELL-KNOWN THERAPEUTIC MODALITY FOR TREATING VARIOUS PEDIATRIC DISEASES. HOWEVER, NO SPECIAL GUIDELINES ARE AVAILABLE FOR PEDIATRIC PATIENTS, AND ADULT GUIDELINES- AMERICAN SOCIETY FOR APHERESIS (ASFA) ARE OLLOWED.AIM: TO STUDY THE SAFETY OF TPE AND ANALYZE THE VARIOUS INDICATIONS FOR WHICH IT CAN BE DONE IN PEDIATRIC PATIENTS. MATERIAL AND METHODS: A 5-YEAR RETROSPECTIVE ANALYSIS OF THE INDICATIONS AND THEIR SAFETY WAS DONE FROM 2018 TO 2022.TPE WAS DONE BY CENTRIFUGATION RESULTS: TPE WAS PERFORMED IN 120 PATIENTS AND 926 PROCEDURES WERE DONE. ANTIBODY-MEDIATED REJECTION (ABMR) AND ATYPICAL HEMOLYTIC UREMIC SYNDROME (A HUS) WERE THE MOST COMMON INDICATIONS WITH (b)(4) OF PROCEDURES EACH. PRE-RENAL TRANSPLANT DESENSITIZATION (8.3%) AND WILSONS DISEASE (2.5%) WERE OTHER INDICATIONS. THE MOST COMMON ADVERSE EVENT SEEN WAS MODERATE (53.57%),AND ALLERGIC REACTION TO REPLACEMENT FLUID -FRESH FROZEN PLASMA (FFP) WAS THE MOST COMMON. V

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23924027 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE "MANAGEMENT OF SEVERE PEDIATRIC GUILLAIN-BARRÉ SYNDROME IN A LOW-INCOME COUNTRY: EFFICACY AND SAFETY OF THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS: A RETROSPECTIVE STUDY" BY ALI, T., HKIMA ABOU FAKHER, F., ALAWIR, M., ALLABABIDI, A., & SHEIKH HASAN, A. ¿PLASMAPHERESIS WAS INITIATED ON AN AVERAGE OF 6.1 ± 2.5 DAYS AFTER THE ONSET OF SYMPTOMS (RANGE: 1 TO 11 DAYS, MEDIAN: 6 DAYS). TPE WAS THE SOLE TREATMENT FOR 29 PATIENTS; THREE PATIENTS RECEIVED IVIG BEFORE TPE, WITH ONE PATIENT DYING FROM SEPTIC SHOCK; AND FOUR PATIENTS RECEIVED IVIG AFTER TPE, WITH TWO TRANSITIONING FROM TPE TO IVIG AFTER TWO TPE SESSIONS DUE TO COMPLICATIONS ASSOCIATED WITH PLASMAPHERESIS.¿ ¿TPE WAS FOUND TO BE GENERALLY SAFE WHEN APPLIED IN THIS COHORT OF PEDIATRIC PATIENTS, AND IT IS ROUTINELY PERFORMED IN OUR HOSPITAL, DESPITE THE CHALLENGES ASSOCIATED WITH ITS APPLICATION. HOWEVER, SOME ADVERSE EVENTS OCCURRED DURING OR AFTER PLASMAPHERESIS SESSIONS, INCLUDING A FEW THAT WERE SERIOUS AND LIFE-THREATENING. WE WILL DESCRIBE THE DETAILS OF THESE COMPLICATIONS NEXT.¿ ¿THROUGHOUT THE COURSE OF 122 TPE SESSIONS, COMPLICATIONS WERE OBSERVED IN 47 SESSIONS (39%) INVOLVING 29 PATIENTS (81%)

  Patient problems: Anaphylactic Shock; Anemia; Arrhythmia; Bradycardia; Convulsion/Seizure; High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Hypoxia; Low Blood Pressure/ Hypotension; Nausea; Pulmonary Edema; Tachycardia; Vomiting

  MAUDE report 21599338 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "HEPATITIS A AND LEPTOSPIROSIS DUAL INFECTION-INDUCED FULMINANT HEPATIC FAILURE SUCCESSFULLY TREATED WITH STANDARD VOLUME THERAPEUTIC PLASMA EXCHANGE", BY U.B. DAVOOD, PANDEEP KAUR, AKARSHAN GUPTA, ANUNEET TRIPATHI, AMIT KUMAR CHATTERJEE, AMIT KUMAR, ANKITA NIGAM, SHOBNA BHATIA, THE SPECTRA OPTIA/C210 APHERESIS SYSTEM WAS UTILIZED FOR THERAPEUTIC PLASMA EXCHANGE IN A PATIENT WITH FULMINANT HEPATIC FAILURE DUE TO DUAL INFECTIONS. DURING THE FIRST PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION, WHICH NECESSITATED THE ADMINISTRATION OF INTRAVENOUS FLUIDS AND NORADRENALINE. THE HYPOTENSION COULD BE ATTRIBUTED TO THE THERAPEUTIC PROCEDURE, REQUIRING MONITORING AND MANAGEMENT DURING SUCH TREATMENTS. SUBSEQUENT PROCEDURES WERE CONDUCTED WITH A SLIGHTLY POSITIVE FLUID BALANCE, AND THE PATIENT'S CONDITION IMPROVED SIGNIFICANTLY. PATIENT IDENTIFICATION IS NOT AVAILABLE AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21595585 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE "LIFE-THREATENING INTRACARDIAC THROMBUS AFTER PLASMAPHERESIS IN A CHILD WITH ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA" BY KILINÇ, B., CANBEYLI, F. H., YAZICI, M. U., & KAYA, Z. ¿THIS IS THE FIRST CASE OF A 17-YEAR-OLD GIRL WITH ATTP WHO DEVELOPED AN INTRACARDIAC THROMBUS AFTER PLASMAPHERESIS AND RESOLVED WITH CATHETER-DIRECTED THROMBOLYTIC THERAPY¿..BASED ON THESE FINDINGS, WE CONCLUDE THAT THE PLASMAPHERESIS PROCEDURE, CVC, PLATELET TRANSFUSION, TRANEXAMIC ACID ADMINISTRATION, AND ATTP WERE ALL RESPONSIBLE FOR THE DEVELOPMENT OF INTRACARDIAC THROMBUS IN OUR CASE." 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. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS.

  Patient problems: Chest Pain; Dyspnea; Tachycardia

  MAUDE report 21584489 ↗
• InjuryOct 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "RISK ANALYSIS OF FLUCTUATING HYPERCALCEMIA AFTER LEUKAPHERESIS IN CELLULAR THERAPY" BY TOMOYASU JO, YASUYUKIARAI, TOSHIO KITAWAKI, MOMOKO NISHIKORI, CHISAKI MIZUMOTO, JUNYA KANDA, KOUHEIYAMASHITA, MIKI NAGAO, AKIFUMITAKAORI, KONDO POTENTIAL ADVERSE EVENT: IN (B)(4) SUBJECTS (B)(4), 1 H POST-LEUKAPHERESIS, ICA CONCENTRATION WAS ABOVE THE UPPER LIMIT OF NORMAL. IN (B)(4) SUBJECTS (B)(4), ICA CON-CENTRATION WAS BELOW THE LOWER LIMIT OF NORMAL RANGE AT THE END OF LEUKAPHERESIS, BUT ROSE ABOVE THE UPPER LIMIT OF THE NORMAL RANGE 1 H AFTER THE END OF LEUKAPHERESIS, WITH A PROMINENT RISE DURING THE FIRST HOUR AFTER THE END. THESE RESULTS SUGGEST THAT HYPERCALCEMIA OCCURS AFTER LEUKAPHERESIS IN THE MAJORITY OF SUBJECTS. CALCIUM SUPPLEMENTATION PROVIDED. 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. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401109 ↗
• InjuryOct 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN CRITICALLY ILL CHILDREN: A SINGLE CENTER EXPERIENCE" BY YAZICI OZKAYA, P., KOÇ, G., ERSAYOGLU, I., CEBECI, K., HEKIMCI OZDEMIR, H., KARADAS, N., YILMAZ KARAPINAR, D., KARAPINAR, B.. POTENTIAL ADVERSE EVENT : ADVERSE EVENTS WERE OBSERVED IN 68 (13.9%) SESSIONS.HYPOTENSION (7.8%) AND HYPOCALCEMIA (5.1%) WERE THET A B L E 1 INDICATIONS FOR THERAPEUTIC PLASMA EXCHANGE AND DISEASE CATEGORY.CLINICAL DIAGNOSIS PATIENTS (%) (N = 154) NUMBER OF TPE SESSIONS (N = 486) ASFA CATEGORYSEPSIS WITH MULTIORGAN DYSFUNCTION SYNDROME 42 (27.3) 104SEPSIS + PREVIOUSLY HEALTHY 15 (9.7) 34 IIISEPSIS + CO-MORBIDITY 27 (17.6) 70 IIIHEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS 14 (9.1) 49 IIILIVER DISEASES 48 (31.2) 148ACUTE LIVER FAILURE 43 (28) 127 IIIWILSON DISEASE 5 (3.2) 21 IRHEUMATOLOGICAL DISEASES 4 (2.6) 34SYSTEMIC LUPUS ERYTHEMATOSUS 3 (1.9) 30 IIGRANULOMATOSIS WITH POLYANGIITIS (GPA) 1 (0.7) 4 IIITHROMBOTIC MICROANGIOPATHY 15 (9.7) 68COMPLEMENT MEDIATED 10 (6.5) 45 IIIINFECTION MEDIATED (STEC HUS) 1 (0.6) 5 IIITMA, TRANSPLANTATION ASSOCIATED 2 (1.3) 8 IIITHROMBOTIC THROMBOCYTOPENIC PURPURA 2 (1.3) 10 IPOISONING 21 (13.6) 37MUSHROOM POISONING 11 (7.1) 25 IID

  Patient problems: Arrhythmia; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension

  MAUDE report 20400227 ↗
• InjuryAug 23, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "RED BLOOD CELL EXCHANGE IN CHILDREN WITH SICKLE CELL DISEASE" BY ELENGA, N., VANTILCKE, V., MARTIN, E., CUADRO, E., SELLES, P., & BASSET, T., THE AIM OF THE STUDY WAS TO ASSESS THE EFFICACY OF RED BLOOD CELL EXCHANGE (RBCX) USING A SPECTRA OPTIA AUTOMATED APHERESIS SYSTEM IN CHILDREN WITH SICKLE CELL DISEASE (SCD). USING AUTOMATED RBCX TO TREAT ACUTE AND CHRONIC COMPLICATIONS IN 75 CHILDREN WITH SCD WHO HAD A MEDIAN AGE OF 10 YEARS [7¿13], 649 RBCX SESSIONS WERE ANALYZED. PERIPHERAL VENOUS ACCESS WAS LIMITED IN A NUMBER OF THE CHILDREN, AND THUS A FEMORAL DOUBLE-LUMEN CENTRAL VENOUS CATHETER, AND HEPARIN LOCKING WITH 500 UNITS IN EACH LUMEN OF THE CATHETER. TO PREVENT COMPLICATIONS, ALL PATIENTS HAD ACHIEVED A POST-RCE HB LEVEL OF <30%. FOR CHRONIC TRANSFUSION, WITH A POST-RCE HB LEVEL OF APPROXIMATELY 10¿11 G/DL, A BLOOD EXCHANGE VOLUME OF =32 ML/KG, AND AN INTERVAL BETWEEN EACH RBCX PROCEDURE OF =30 DAYS, THE RESIDUAL HBS LEVEL WAS MAINTAINED BELOW 30%. FOR ACUTE TRANSFUSION, A POST-EXCHANGE HB LEVEL =10 G/DL (P<0.001) AND A TOTAL EXCHANGE VOLUME =35 ML/KG (P=0.001) WAS THE BEST WAY TO REDUCE HBS TO<30%. AUC WAS 0.84. RESULTS SHOWED THAT ERYTHROCYTAPHERESIS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 20052196 ↗
• MalfunctionAug 23, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "THERAPEUTIC PLASMA EXCHANGE IN HELLP SYNDROME: A LIFE SAVIOR". BY CHOWDHRY, M., AGRAWAL, S., GAJULAPALLI, S. P., THAKUR, U. K POTENTIAL ADVERSE EVENT : THREE AMPOULES OF INJECTION CALCIUM GLUCONATE 10% DILUTED IN NORMAL SALINE WAS ADMINISTERED AS A PROPHYLAXIS FOR ACID CITRATE DEXTROSE (ACD) INDUCED HYPOCALCEMIA. THE PROCEDURES WERE WELL TOLERATED AND THERE WAS NO SERIOUS COMPLICATION TO THE PATIENT DURING OR AFTER THE PROCEDURE. OUT OF THE TOTAL NINE PATIENTS, TWO PATIENTS (22.2%) RECOVERED COMPLETELY AND WERE DISCHARGED ON DAY 15 ± 7 DAYS, WHEREAS 4 (44.4%) PATIENTS WERE DISCHARGED ON DAY 21 ± 7 DAYS WITH THE ADVICE OF HEMODIALYSIS DUE TO PERSISTING KIDNEY INJURY. TWO (22.2%) PATIENTS HAD AN INTRAUTERINE DEATH AND WERE DISCHARGED 3¿4 DAYS AFTER THE DEMISE. IN ALL THESE PATIENTS, THE TPE WAS INITIATED WITHIN 24 H OF THE DIAGNOSIS. ONE PATIENT (11.1%) WAS REFERRED FROM A PRIMARY HEALTH-CARE CENTER OF A TWO-TIER CITY AND COULD BE ATTENDED ONLY AFTER A WEEK. ONLY ONE PLASMA EXCHANGE COULD BE PERFORMED ON THIS PATIENT AFTER THE ELECTIVE LOWER SEGMENT CAESAREAN SECTION (LSCS). SHE LATER SUCCUMBED TO ACUTE RENAL FAILURE AND DIC. THE COLLECTION SET IS NOT AVAILABLE F

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052096 ↗
• MalfunctionAug 23, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) ON A SPECTRA OPTIA DEVICE, THE SYSTEM DISPLAYED THE ERROR MESSAGE "AIM SYSTEM SAW RED BLOOD CELLS NEAR TOP OF CONNECTOR". THE OPERATOR REPORTED THAT THE PLASMA WAS DARK DUE TO THE PATIENT'S LIVER FAILURE. PER THE CUSTOMER, THE DEVICE ERROR MESSAGE DID NOT HAVE THE OPTION TO DISABLE THE AIM SYSTEM, AND THE OPERATOR TERMINATED THE PROCEDURE. PATIENT ID, AGE AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049399 ↗
• MalfunctionAug 22, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) ON A SPECTRA OPTIA DEVICE, THE SYSTEM DISPLAYED THE ERROR MESSAGE "AIM SYSTEM SAW RED BLOOD CELLS NEAR TOP OF CONNECTOR". THE OPERATOR REPORTED THAT THE PLASMA WAS DARK DUE TO THE PATIENT'S LIVER FAILURE. PER THE CUSTOMER, THE DEVICE ERROR MESSAGE DID NOT HAVE THE OPTION TO DISABLE THE AIM SYSTEM, AND THE OPERATOR TERMINATED THE PROCEDURE. PATIENT ID, AGE AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043640 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "EFFICACY AND SAFETY OF THERAPEUTIC PLASMA EXCHANGE IN CHILDREN WITH NEUROIMMUNOLOGICAL DISORDERS: A LIMITED UNICENTRAL STUDY", BY NIKKHAH, A., NASEHI, M. M., MOMTAZMANESH, N., ETEMAD, K., & HAJATNIA, S., PATIENTS RECEIVED THERAPEUTIC PLASMA EXCHANGE (TPE) WITH A COMBINATION OF FRESH FROZEN PLASMA (FFP) (80-20%) AND 5% ALBUMIN WITH 5-10 CYCLES EVERY OTHER DAY. PATIENTS WITH PULMONARY NON-INFECTIOUS DISEASE (PNID) RECEIVED 121 TPE CYCLES. THE PRESENT RESEARCH INVESTIGATED TPE-RELATED COMPLICATIONS IN SUBGROUPS. OUT OF ALL THE TPE CYCLES, THREE CYCLES (2.48%) IN THE AUTOIMMUNE ENCEPHALITIS (AIE) SUBGROUP, TWO (1.65%) IN GUILLAIN-BARRE SYNDROME (GBS), FIVE (4.13%) IN MULTIPLE SCLEROSIS (MS), AND ONE (0.82%) IN ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM), AND NO CYCLES IN NEUROMYELITIS OPTIC SPECTRUM DISORDER (NMOSD) AND OPTIC NEURITIS (ON) SUBGROUPS SHOWED ADVERSE EFFECTS. GRADE 1 (AS PER CTCAE) CHILL WAS OBSERVED IN THREE CYCLES (2.48%) OF MS AND AIE PATIENTS, GRADE 1 TACHYCARDIA IN 3 CYCLES (2.48%) OF GBS, MS, AND AIE PATIENTS, GRADE 3 URTICARIA IN TWO CYCLES (1.65%) OF GBS AND PATIENTS WITH MS. MOREOVER, GRADE 2 HYPERTENSION, GRADE 1 DYSPNEA, AND GRADE 1 NAUSEA

  Patient problems: Chills; Dyspnea; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Nausea; Tachycardia; Urticaria

  MAUDE report 20041684 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "PLASMAFÉRESE TERAPÊUTICA: AVALIAÇÃO DOS PROCEDIMENTOS DE ACORDO COM AS DIRETRIZES INTERNACIONAIS". BY, DELAMAIN, M.T., GONTIJO, P.C., SANTOS, F.S.D., MATOS, C.T.S., NASCIMENTO, V.Z.D., MIRANDA, D.M., COELHO, M.V.P., DINIZ, A.P., OLIVEIRA, R.A.S.F., PORTO, T.H.A., COSTA, A.L. POTENTIAL ADVERSE EVENT : 4 PATIENTS WERE IDENTIFIED WHO PRESENTED ADVERSE REACTION DURING THE PROCEDURE, 1 BEING A FEBRILE REACTION NON-HEMOLYTIC TO PLASMA, 1 ARTERIAL HYPOTENSION, 1 REFLEX VASOVAGAL AND ARTERIAL HYPOTENSION AND 1 PATIENT PRESENTED ~ EDEMA OF THE TONGUE, EYELIDS AND URTICARIA ON THE FACE. AS FOR THE INDICATION CRITERIA, THE VAST MAJORITY OF 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. HIS WAS A JOURNAL PUBLICATION TO ASSESS THERAPEUTIC PLASMAPHERESIS BY EVALUATING PROCEDURES ACCORDING TO INTERNATIONAL GUIDELINES BETWEEN APRIL 2021 AND JUNE 2023, WHERE 66 PATIENTS WERE EVALUATED, 62% OF WHOM WERE FEMALE, WITH A MEDIAN AGE OF 38 YEARS (5-93). A REQUEST

  Patient problems: Low Blood Pressure/ Hypotension; Swelling/ Edema; Urticaria

  MAUDE report 19962610 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "EFFECT OF TPE VS MEDICAL MANAGEMENT ON PATIENT OUTCOMES IN THE SETTING OF HYPERTRIGLYCERIDEMIA-INDUCED ACUTE PANCREATITIS WITH SEVERELY ELEVATED TRIGLYCERIDES", BY WEBB, C. B., LEVENO, M., QUINN, A. M., & BURNER, J., HYPERTRIGLYCERIDEMIA-INDUCED ACUTE PANCREATITIS (HTG-AP) ACCOUNTS FOR 1 TO 10% OF PANCREATITIS CASES AND IS ASSOCIATED WITH A MORE SEVERE CLINICAL COURSE. THERAPEUTIC PLASMA EXCHANGE (TPE) IS A POTENTIAL TREATMENT OPTION FOR QUICKLY LOWERING PLASMA TRIGLYCERIDES (TG). CURRENT ASFA GUIDELINES DEFINE HTG-AP AS A CATEGORY III DISORDER, INDICATING THE ROLE OF APHERESIS IS NOT FIRMLY ESTABLISHED. HERE, WE EXAMINE CLINICAL DATA REGARDING ITS EFFECTIVENESS ON MORBIDITY AND MORTALITY IN PATIENTS WITH HTG-AP PRESENTING WITH SEVERELY ELEVATED PLASMA TRIGLYCERIDES (>4000 MG/DL). WE RETROSPECTIVELY EXAMINED CLINICAL DATA AND OUTCOMES FROM 67 CONSECUTIVE EPISODES OF HTG-AP OVER A 5-YEAR PERIOD IN WHICH EITHER MEDICAL MANAGEMENT ALONE OR MEDICAL MANAGEMENT PLUS ADJUNCT TPE WAS EMPLOYED TO REDUCE PLASMA TRIGLYCERIDES. 16/67 ADMISSIONS INVOLVED TPE, INITIATED AT A MEAN OF 0.7 DAYS FROM THE TIME OF PRESENTATION, WHILE 51 RECEIVED MEDICAL MANAGEMENT ALONE. AFTER ON

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension

  MAUDE report 19962384 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "REDUCED VOLUME OF RED BLOOD CELL PRIMING IS SAFE FOR PEDIATRIC PATIENTS UNDERGOING THERAPEUTIC PLASMA EXCHANGE", BY "LUZZI, J. R., BORBA, C. C., MIYAJI, S. C., BRITO, C. A., NAVARRO-XAVIER, R., & DINARDO, C. L.", THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURES IN PEDIATRIC PATIENTS ARE CHALLENGING DUE TO THE LARGE EXTRACORPOREAL VOLUME OF THE CELL SEPARATORS, WHICH WERE DESIGNED FOR ADULTS. RED BLOOD CELL (RBC) PRIMING IS AN ALTERNATIVE FOR OVERPASSING THE RISKS OF HYPOVOLEMIA, BUT DATA REFERRING TO THE VOLUME OF PACKED RBCS TO BE INFUSED ARE YET INCOMPLETE. RESTRICTING THE VOLUME OF RBC PRIMING MAY POTENTIALLY BE ASSOCIATED WITH LESS TRANSFUSION REACTIONS. TO DETERMINE THE SAFETY OF ADMINISTERING A REDUCED VOLUME OF RBC PRIMING FOR PEDIATRIC PATIENTS UNDERGOING TPE, IN COMPARISON TO THE STANDARD VOLUME RECOMMENDED BY THE CELL SEPARATORS¿ MANUFACTURERS. THIS WAS A CASE-CONTROL STUDY WHICH ENROLLED 15 PEDIATRIC PATIENTS UNDERGOING TPE AND WEIGHTING MORE THAN 10KG. THE TPE PROCEDURES (N = 406) WERE DIVIDED IN TWO GROUPS: 1) GROUP1: TPE WITH =150 ML OF PACKED RBC PRIMING AND 2) GROUP2: TPE WITH 150-250 ML OF RBC PRIMING. GROUPS WERE COMPARED IN TERMS OF HEMOGLOBIN /

  Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Syncope/Fainting

  MAUDE report 19961773 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "A LOWER FIBRINOGEN THRESHOLD DOES NOT LEAD TO INCREASED BLEEDING RISK IN PATIENTS RECEIVING THERAPEUTIC PLASMA EXCHANGE: A PROSPECTIVE SINGLE-CENTER ANALYSIS" BY WODAJO, A., SARODE, R., VALIYAPARAMBIL, S., WEBB, C., DE SIMONE, N., REBECCA, D., & USMANI, A., PLASMA EXCHANGE (PLEX) THERAPY IS INDICATED FOR SEVERAL DISORDERS. THE 5% ALBUMIN IS OFTEN USED AS A SOLE REPLACEMENT FLUID DURING MOST PLEX. HOWEVER, EACH 1.0 PLASMA VOLUME EXCHANGE DEPLETES COAGULATION FACTORS BY ~65%. ALTHOUGH MOST COAGULATION FACTORS RECOVER TO HEMOSTATIC LEVELS WITHIN 24 H POST-PLEX, FIBRINOGEN REQUIRES 48¿¿¿72 H TO RECOVER. FIBRINOGEN IS THE KEY COAGULATION PROTEIN FOR HEMOSTASIS. THEREFORE, FIBRINOGEN IS OFTEN MONITORED DURING THE ACUTE COURSE OF PLEX, AND PLASMA IS SUPPLEMENTED TO PREVENT BLEEDING IF FIBRINOGEN IS ¿¿¿100 MG/DL. WE CONDUCTED A PROSPECTIVE, SINGLE-CENTER, OBSERVATIONAL STUDY TO EVALUATE BLEEDING RISK IN ADULTS WHO RECEIVED AN ACUTE COURSE OF PLEX WITH A FIBRINOGEN LEVEL OF 80¿¿¿100 MG/DL WITHOUT PLASMA SUPPLEMENTATION DURING THE PROCEDURE OR BEFORE CENTRAL VENOUS CATHETER REMOVAL. THE STUDY GROUP WAS COMPARED TO PATIENTS WITH PLASMA FIBRINOGEN ¿¿¿100 MG/DL. RESULTS: A

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19864981 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "THERAPEUTIC PLASMA EXCHANGE IN NEUROMYELITIS OPTICA SPECTRUM DISORDERS AND RELATED DISORDERS IN RESOURCE-LIMITED SETTINGS: OUTCOMES IN A MULTIETHNIC SINGLE-CENTER POPULATION" BY ONG, Z. M., SCHEE, J. P., & VISWANATHAN, S. (2019), THERAPEUTIC PLASMA EXCHANGE (TPE) EFFICIENCY IN TREATMENT OF A SINGLE RELAPSE IN STEROID REFRACTORY PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDERS (NMOSD) IN A MULTI-ETHNIC RESOURCE-LIMITED SETTING WAS EVALUATED. THIS WAS A HISTORICAL COHORT STUDY ON THE CLINICAL OUTCOMES POST-TPE IN A MULTIETHNIC COHORT OF 53 STEROID-REFRACTORY NMOSD PATIENTS AT A SINGLE MALAYSIAN TERTIARY CENTER. PRIMARY OUTCOMES, ASSESSED BOTH PRE- AND POST-TPE, WERE MEDICAL RESEARCH COUNCIL SCALE OF MUSCLE POWER, MODIFIED RANKIN SCALE, EXPANDED DISABILITY STATUS SCALE (EDSS), AND VISUAL ACUITY. SECONDARY OUTCOMES WERE AMBULATORY STATUS AND TARGET NEUROLOGICAL DEFICIT (TND)-BASED TPE RESPONSE. SIGNIFICANT IMPROVEMENTS IN MEDICAL RESEARCH COUNCIL, MODIFIED RANKIN SCALE, EDSS, AND VISUAL ACUITY (P < 0.001) WERE OBSERVED AT 1-MONTH POST-TPE WITH FURTHER IMPROVEMENT OF EDSS AT 6 MONTHS (EDSS¿6) POST-TPE (P = 0.001). AT 6 MONTHS POST-TPE, 87% OF PATIENTS HAS SUCC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension; Sepsis

  MAUDE report 19863575 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE, "VARIABLE RESPONSE TO THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC ANTI-NMDA RECEPTOR ENCEPHALITIS" BY NAIK, A., PRAKASH, S., RAY, G. K., & MUKHERJEE, S. (2021), ANTI-NMDA RECEPTOR ENCEPHALITIS IN AN ACUTE FORM GENERALLY PRESENTS WITH ABNORMAL MOVEMENTS AND PSYCHIATRIC SYMPTOMS. THERAPEUTIC PLASMA EXCHANGE HAS BEEN CONSIDERED TO BE ONE OF THE FIRST-LINE TREATMENT OPTIONS. THIS REPORT HIGHLIGHTS THE ROLE OF PLASMA EXCHANGE IN ANTI-NMDA RECEPTOR ENCEPHALITIS IN PEDIATRIC PATIENTS. THIS IS A RETROSPECTIVE ANALYSIS OF FOUR CASES OF A SEVERE FORM OF ENCEPHALITIS DUE TO ANTI-NMDA RECEPTOR ANTIBODY. ALL THESE FOUR PATIENTS WERE EVALUATED FOR CLINICAL AND LABORATORY PROFILE BEFORE PLASMA EXCHANGE. PLASMA EXCHANGE WAS PERFORMED WITH COBE SPECTRA VERSION 7.0(TERUMO BCT, USA), AND 5% ALBUMIN AND FRESH FROZEN PLASMA WERE USED AS REPLACEMENT FLUID. A TOTAL OF 20 PROCEDURES (RANGE: 2¿8/PATIENT) WERE PERFORMED ON FOUR PATIENTS ON AN ALTERNATE DAY BASIS. SLOW RECOVERY AND LONG-TERM HOSPITALIZATION (RANGE: 25¿70 DAYS) WAS OBSERVED IN ALL THESE PATIENTS AND MAY BE DUE TO DELAYED INITIATION OF PLASMA EXCHANGE. ONE PATIENT WAS LOST IN FOLLOW UP WHILE ANOTHER ONE HAD FATAL CONSEQUENCES

  Patient problems: Low Blood Pressure/ Hypotension; Rash

  MAUDE report 19575559 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19575313 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "ROLE OF PLASMA EXCHANGE IN A STEROID- AND IVIG-REFRACTORY PATIENT WITH ACUTE DISSEMINATED ENCEPHALOMYELITIS: A CASE REPORT" BY TRIPATHI, P. P., HANS, R., SHARMA, R. R., LAMBA, D. S., PAUL, P., SANKHYAN, N., BHAGWAT, C., & SINGH, P. (2020), AN 8-YEAR BOY PRESENTED WITH LIMB WEAKNESS AND COMPLETE LOSS OF VISION AND WAS RESISTANT TO STEROID THERAPY. HE WAS FURTHER TREATED WITH THERAPEUTIC PLASMA EXCHANGE (TPE) AND FIVE SESSIONS WERE GIVEN ON EVERY ALTERNATE DAY USING A CENTRAL FEMORAL LINE DIALYSIS CATHETER AS VASCULAR ACCESS ON AUTOMATED CELL SEPARATORS COBE SPECTRA AND OPTIA SPECTRA. A TOTAL OF 4% OF HUMAN SERUM ALBUMIN WAS USED AS REPLACEMENT FLUID DURING EACH SESSION OF PLASMA EXCHANGE. DURING EACH SESSION, 1% CALCIUM GLUCONATE INFUSION WAS GIVEN THROUGH VENULAR ACCESS TO OVERCOME ANY COMPLICATIONS RELATED TO HYPOCALCEMIA. ALL TPE PROCEDURES WERE UNEVENTFUL EXCEPT FOR THE FIRST ONE WHERE THE PATIENT COMPLAINED OF SHIVERING FOLLOWED BY VOMITING AND HYPOTENSION WHICH WAS MANAGED CONSERVATIVELY WITH INTRAVENOUS FLUID 0.9% NORMAL SALINE BOLUS. AFTER COMPLETION OF THE TPE SESSIONS, THE PATIENT SHOWED IMPROVEMENT IN VISION AND STARTED TO REGAIN HIS POWER. HE WAS DIS

  Patient problems: Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 19575017 ↗