BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 19962384 · Received August 12, 2024

    Report

    Report Number
    1722028-2024-00338
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    June 22, 2021
    Report Date
    August 12, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583102200
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. WEBB, C. B., LEVENO, M., QUINN, A. M., & BURNER, J. (2021). EFFECT OF TPE VS MEDICAL MANAGEMENT ON PATIENT OUTCOMES IN THE SETTING OF HYPERTRIGLYCERIDEMIA INDUCED ACUTE PANCREATITIS WITH SEVERELY ELEVATED TRIGLYCERIDES. JOURNAL OF CLINICAL APHERESIS, 36(5), 719726. HTTPS://DOI.ORG/10.1002/JCA.21922

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.2, B.5, H.6 AND H.11 AND CORRECTED INFORMATION IN D.1. INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION OUTLINING A RETROSPECTIVE STUDY FOR PATIENT ADMISSIONS FOR HYPERTRIGLYCERIDEMIA-INDUCED ACUTE PANCREATITIS (HTG-AP) UNDERGOING TPE PROCEDURES BETWEEN JANUARY 2014 AND JULY 2019 AT PARKLAND HOSPITAL AND HEALTH SYSTEMS, DALLAS, TX, THE DISPOSABLE 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. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: HYPERTRIGLYCERIDEMIA-INDUCED ACUTE PANCREATITIS (HTG-AP) IS A FORM OF PANCREATITIS INDUCED BY HIGH PLASMA TRIGLYCERIDES (TG). WHILE THE UNDERLYING MECHANISMS ARE NOT FULLY ELUCIDATED, THE LEADING HYPOTHESIS INVOLVES INCREASED HYDROLYSIS OF TG BY PANCREATIC LIPASE, CREATING EXCESSIVE LEVELS OF FREE FATTY ACIDS WHICH ACT AS PRO INFLAMMATORY MEDIATORS THAT RESULT IN CYTOTOXIC DAMAGE AND CAPILLARY INJURY WITHIN THE PANCREAS. CHYLOMICRONS, WHICH ARE INCREASED IN THE SETTING OF SEVERE HYPERTRIGLYCERIDEMIA (HTG), MAY ALSO PLAY A ROLE VIA INCREASED CAPILLARY VISCOSITY, LEADING TO LOCAL ISCHEMIA AND ACIDEMIA. MANAGEMENT OF HTG-AP IS SIMILAR TO ACUTE PANCREATITIS (AP) DUE TO OTHER CAUSES AND IS PRIMARILY SUPPORTIVE, INCLUDING FLUID RESUSCITATION, ANALGESIA, AND NUTRITIONAL SUPPORT. IN ADDITION, INTERVENTIONS TO SPECIFICALLY ADDRESS HTG ARE USUALLY INCLUDED AS PART OF THE MANAGEMENT STRATEGY. THESE MEASURES INCLUDE DIETARY RESTRICTION, LIPID-LOWERING AGENTS (EG, FIBRATES), INTRAVENOUS INSULIN, AND HEPARIN, OF WHICH THE LATTER TWO INCREASE CHYLOMICRON BREAKDOWN AND TG CLEARANCE BY STIMULATING LPL SYNTHESIS AND ACTIVITY. THE USE OF THERAPEUTIC PLASMA EXCHANGE (TPE) HAS BEEN DESCRIBED FOR HTG-AP, THOUGH IT IS CURRENTLY DESIGNATED AS A CATEGORY III DISORDER BY THE AMERICAN SOCIETY OF APHERESIS (ASFA), INDICATING THAT THE ROLE OF APHERESIS IS NOT FIRMLY ESTABLISHED. THE RATIONALE FOR ITS USE IS ITS ABILITY TO RAPIDLY DECREASE TG LEVELS (49-97% REDUCTIONS IN TG HAVE BEEN REPORTED FOLLOWING A SINGLE TPE PROCEDURE) AS WELL AS ITS POTENTIAL TO REDUCE INFLAMMATORY CYTOKINES AND REPLACE DEFICIENT LPL (WHEN PLASMA IS USED AS REPLACEMENT FLUID). FIFTY-ONE PATIENTS WITH 67 UNIQUE ADMISSIONS FOR HTG AP THAT OCCURRED BETWEEN JANUARY 2014 AND JULY 2019 AT PARKLAND HOSPITAL AND HEALTH SYSTEMS, DALLAS, TX, WERE INCLUDED IN THIS STUDY. INCLUSION CRITERIA INCLUDED ADMISSIONS WITH VERY HIGH LEVELS OF PLASMA TG (>4000 MG/DL). LEVELS >4425 MG/DL WERE REPORTED AS >4425 DUE TO THE LIMIT OF DETECTION, AND THESE PATIENTS WERE CONSIDERED TO HAVE A LEVEL OF PRECISELY 4425 MG/DL FOR THE PURPOSES OF ANALYSIS. PATIENTS WERE EXCLUDED IF TG < 4000 MG/DL, OR IF THEY LACKED AT LEAST TWO OF THE THREE FOLLOWING DIAGNOSTIC CRITERIA FOR AP: ABDOMINAL PAIN, ELEVATED SERUM LIPASE (>3 TIMES NORMAL), AND/OR CHARACTERISTIC FINDINGS ON IMAGING. PLASMA TG LEVELS AT ADMISSION WERE OBTAINED (CONSIDERED DAY 0), AS WELL AS EVERY SUBSEQUENT HOSPITAL DAY UP TO DAY 9, AND AT DISCHARGE. PATIENT BEDSIDE INDEX OF SEVERITY IN ACUTE PANCREATITIS (BISAP) SCORE WAS RECORDED FOR EACH ADMISSION, AS WELL AS LENGTH OF HOSPITAL STAY, CONDITION AT DISCHARGE, TREATMENT DETAILS, AND OTHER HOSPITAL COMPLICATIONS. PATIENTS WERE ASSIGNED TO A ¿MEDICAL¿ GROUP OR A ¿TPE¿ GROUP IF THEY RECEIVED MEDICAL MANAGEMENT ALONE VS MEDICAL MANAGEMENT PLUS TPE, RESPECTIVELY. 51 ENCOUNTERS (76%) WERE INCLUDED IN THE MEDICAL GROUP, AND 16 (24%) ENCOUNTERS WERE INCLUDED IN THE TPE GROUP TOTALLING 67 ADMISSIONS. DEPENDING ON THE PRESENCE OF MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS), PATIENTS IN THE ¿TPE¿ CATEGORY WERE FURTHER SUBDIVIDED INTO A ¿MODS¿ SUBGROUP (FIVE PATIENTS) OR ¿NON-MODS¿ SUBGROUP (11 PATIENTS). FOR THE TPE SUBSET, THE NUMBER OF TPE PROCEDURES, THE DAY OF TPE, THE PRE- AND POST-TPE TG LEVELS, PERCENT REDUCTION IN TG, EXCHANGE VOLUME, REPLACEMENT FLUID, AND ANY COMPLICATIONS RESULTING FROM TPE WERE RECORDED. THE PRE- AND POST-TPE TG LEVELS WERE THE LEVELS OBTAINED CLOSEST TO STARTING TPE AND THE FIRST VALUE OBTAINED AFTER THE COMPLETION OF TPE, RESPECTIVELY. THE MEAN TIME BETWEEN TPE AND REPEAT TG MEASUREMENT WAS 106 ± 190 MIN POST PROCEDURE. PROCEDURES WERE PERFORMED VIA PERIPHERAL INTRAVENOUS CATHETERS OR CENTRAL DOUBLE LUMEN TYPE CATHETER USING AN OPTIA APHERESIS DEVICE (TERUMO BCT, DENVER, CO). ACID CITRATE DEXTROSE SOLUTION WAS USED AS AN ANTICOAGULANT. 18 TOTAL TPE PROCEDURES WERE PERFORMED IN 16 PATIENTS. ONE PATIENT HAD A SERIES OF THREE CONSECUTIVE TPE PROCEDURES PERFORMED OVER 2 HOSPITAL DAYS, WHILE ALL OTHER PATIENTS RECEIVED A SINGLE SESSION. 15 PROCEDURES WERE 1.5 PLASMA VOLUME EXCHANGES, TWO PROCEDURES WERE 1.2 PLASMA VOLUME EXCHANGES, AND ONE PROCEDURE WAS STOPPED PREMATURELY AT 1.0 PLASMA VOLUME (OUT OF A PLANNED 1.5 PLASMA VOLUME) DUE TO SIGNIFICANT PAIN DURING THE PROCEDURE AND PATIENT REQUEST. FIVE PERCENT ALBUMIN WAS USED AS THE REPLACEMENT FLUID FOR ALL BUT THREE PROCEDURES, WHICH USED A COMBINATION OF 5 % ALBUMIN AND FRESH FROZEN PLASMA (FFP) DUE TO MULTIPLE ORGAN DYSFUNCTION. THE MOST COMMON COMORBIDITY WAS TYPE II DIABETES MELLITUS (75%). OTHER DOCUMENTED COMORBIDITIES INCLUDED HYPERTENSION, A HISTORY OF ALCOHOL ABUSE, PREDIABETES, HYPOTHYROIDISM, TYPE 1 DIABETES, AND FAMILIAL LIPOPROTEIN LIPASE DEFICIENCY. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS WITH RESPECT TO UNDERLYING COMORBIDITIES. THE MOST COMMON COMPLICATIONS AT PRESENTATION WERE DIABETIC KETOACIDOSIS (46%), THE SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS)/SEPSIS (39%), NECROTIZING PANCREATITIS (15%), AND MULTIORGAN DYSFUNCTION (8%). PATIENTS WHO RECEIVED TPE WERE MORE LIKELY TO PRESENT WITH SIRS/SEPSIS, INCLUDING THOSE IN THE NON-MODS SUBGROUP. THOSE WHO RECEIVED TPE WERE ALSO MORE LIKELY TO PRESENT WITH NECROTIZING PANCREATITIS (P=.04), THOUGH THIS DID NOT HOLD TRUE AFTER EXCLUDING THOSE WITH MODS. ALL PATIENTS WITH MULTI ORGAN DYSFUNCTION RECEIVED TPE (FOUR PATIENTS RECEIVED A SINGLE PROCEDURE, WHILE ONE PATIENT UNDERWENT THREE CONSECUTIVE PROCEDURES OVER THE COURSE OF 2 HOSPITAL DAYS). PLASMA LIPASE LEVELS (U/L) AND LIVER FUNCTION TESTS (LFTS) WERE ALSO MONITORED DURING HOSPITALIZATION. THE PEAK AST AND PEAK ALT WERE SIGNIFICANTLY DIFFERENT BETWEEN MEDICALLY MANAGED PATIENTS AND THE TPE GROUP (P < .001 AND P=.01, RESPECTIVELY). THIS DIFFERENCE WAS ALSO SIGNIFICANT WHEN COMPARING THE MEDICAL GROUP TO THE TPE (NON-MODS) GROUP (P=.03 AND P=.05, RESPECTIVELY). THERE WAS NO STATISTICAL SIGNIFICANCE BETWEEN THE MEDICAL AND TPE GROUPS WITH REGARDS TO LIPASE (P=.37) OR ALKALINE PHOSPHATASE (P=.43). REGARDING TERUMO BCT PRODUCT, SPECTRA OPTIA, NO SERIOUS COMPLICATIONS OF TPE WERE REPORTED. THREE PROCEDURES (16%) WERE ASSOCIATED WITH MILD HYPOTENSIVE EPISODES THAT RESOLVED WITH ADMINISTRATION OF NORMAL SALINE (NS). ONE PROCEDURE WAS ASSOCIATED WITH A CLOTTED LINE THAT WAS ADDRESSED WITH ALTEPLASE, AND ONE PATIENT EXPERIENCED MILD SYMPTOMS OF HYPOCALCEMIA SECONDARY TO CITRATE TOXICITY THAT IMPROVED WITH ORAL CALCIUM CARBONATE. THE AUTHORS REPORTED THAT ONE PATIENT IN THE TPE GROUP DIED DURING HOSPITALIZATION. THE AUTHORS EXPLAINED THAT THOSE WHO RECEIVED TPE WERE MORE LIKELY TO HAVE PRESENTED WITH SIRS/SEPSIS, IF THE SIRS WAS SEVERE, THEN IT CAN LEAD TO MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS) AND MULTISYSTEM ORGAN FAILURE (MOF). ALL PATIENTS WITH MULTI ORGAN DYSFUNCTION RECEIVED TPE. AS PER TABLE 1 BELOW, MORTALITY WAS LISTED FOR ONE PATIENT (6.2%), WITHIN THE 5 CASES OF MODS IN THE ¿TPE GROUP¿. THEREFORE THE DEATH WAS NOT ALLEGED AS A COMPLICATION OF TPE PROCEDURE, BUT RATHER DUE TO THE PRESENTATION OF THE PATIENT AND THEIR DISEASE STATE AND THE FURTHER COMPLICATION OF THEIR HOSPITAL COURSE BY MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS). THE AUTHORS CONCLUDED THAT OVERALL, PATIENTS UNDERGOING TPE REACHED TG <1000 MG/DL FASTER THAN THE MEDICAL GROUP (T=1.47 DAYS). THE LOWER TG LEVELS IN THE TPE GROUP COMPARED WITH THE MEDICAL GROUP WERE STATISTICALLY SIGNIFICANT AT HOSPITAL DAYS 1, 2, AND 4, WITH A TREND TOWARD SIGNIFICANCE ON DAY 3 (P=.07). THE DIFFERENCE IN TG BECAME STATISTICALLY INSIGNIFICANT BEYOND DAY 4 EXCEPT FOR THE TIME OF DISCHARGE, IN WHICH THE MEDICAL GROUP HAD A SIGNIFICANTLY HIGHER TG LEVEL (P=.003). OVERALL, PATIENTS IN THE TPE GROUP TENDED TO HAVE HIGHER SERUM LIPASE (1112 VS 696 U/L), BE SICKER AT PRESENTATION (BISAP SCORE OF 1.7 VS 1.0), AND HAVE LONGER LOS (11.1 VS 6.5 DAYS). ONE PATIENT IN THE TPE GROUP DIED DURING HOSPITALIZATION (6.3%), WHILE NONE OF THE MEDICAL PATIENTS DIED (0%). HOWEVER, THE DATA IN THE TPE GROUP WERE HEAVILY INFLUENCED BY THE PRESENCE OF FIVE OUTLIER PATIENTS WHOSE HOSPITAL COURSES WERE COMPLICATED BY MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS). COMPARING THE MEDICAL GROUP TO THE ¿NON-MODS¿ TPE SUBGROUP, THE TWO SHOW NO STATISTICALLY SIGNIFICANT DIFFERENCE WITH REGARDS TO LOS, BISAP SCORE, MORTALITY, OR LIPASE AT PRESENTATION. THE ONLY STATISTICALLY SIGNIFICANT LABORATORY DIFFERENCE BETWEEN THE MEDICAL AND ¿NON-MODS¿ SUBGROUP WAS SEEN IN THE PEAK AST AND ALT. UNDERLYING COMORBIDITIES WERE NOT SIGNIFICANT BETWEEN ANY OF THE EXAMINED GROUPS. THE PRO-INFLAMMATORY RESPONSE IN SEVERE ACUTE PANCREATITIS CAN RESULT IN THE SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS). IF SIRS IS SEVERE, IT CAN LEAD TO MODS AND MULTISYSTEM ORGAN FAILURE (MOF). ADDITIONALLY, WITH PANCREATIC NECROSIS, THE RISK OF INTESTINAL FLORA TRANSLOCATION AND INFECTION OF THE NECROTIC TISSUE CAN RESULT IN SEPSIS AND MOF. IN CONCLUSION, THESE FINDINGS SUGGEST THAT IN UNCOMPLICATED CASES OF HTG-AP WITH AN ABSENCE OF MULTIORGAN DYSFUNCTION, THERE IS NO SIGNIFICANT BENEFIT TO EITHER LOS OR MORTALITY WHEN ADDING ADJUNCT TPE TO MEDICAL MANAGEMENT. HOWEVER, IN SEVERE CASES, ESPECIALLY THOSE COMPLICATED BY MODS/MOF, THE AUTHORS FEEL IT IS REASONABLE AND EVEN PRUDENT TO CONSIDER TPE, BOTH FOR THE SLIGHTLY INCREASED RAPIDITY IN TG CLEARANCE, AS WELL AS TO IMPROVE ORGAN FUNCTION BY REMOVING INFLAMMATORY AND ANTIFIBRINOLYTIC MEDIATORS PRESENT IN MODS. IN RELATION TO THE REPORTED CLOTTING, BASED ON EXISTING INTERNAL RISK ASSESSMENTS WHICH INCORPORATE RISK TO PATIENTS OR DONORS COMPARED TO OCCURRENCE RATES, THIS FAILURE DOES NOT HAVE A HIGH RISK. 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. 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. ROOT CAUSE: A ROOT CAUSE ASSESSMENT FOR THE ADVERSE PATIENT REACTIONS WAS PERFORMED FOR THIS COMPLAINT. THE REPORTED ADVERSE EVENTS (HYPOTENSION) ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY FLUID SHIFT, BLOOD LOSS, LENGTH OF THE PROCEDURE, DONOR'S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE DROP IN IONIZED CALCIUM. A DECREASED IONIZED CALCIUM IN CIRCULATION IS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY PATIENT PHYSIOLOGY, THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE CITRATE CONTENTS IN THE REPLACEMENT FLUID, 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. 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 PATIENT PHYSIOLOGY, THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE CITRATE CONTENTS IN THE REPLACEMENT FLUID, 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. THE CUSTOMER REPORTED A CLOTTED LINE. A ROOT CAUSE INVESTIGATION WAS PERFORMED FOR THIS COMPLAINT. IT IS POSSIBLE THAT THE CLOTTING REPORTED DURING THIS PROCEDURE WAS RELATED TO THE PATIENT DISEASE STATE AND/OR BLOOD PHYSIOLOGY AND/OR INADEQUATE ANTICOAGULATION OF THE EXTRACORPOREAL CIRCUIT. THE LIKELIHOOD FOR PLATELET CLUMPING TO OCCUR DURING A RUN IS DIFFICULT TO PREDICT SINCE IT IS NOT DEPENDENT ON A SPECIFIC PLATELET COUNT AND VARIES BY PATIENT. THEREFORE, EVERY PROCEDURE SHOULD BE OBSERVED FOR CLUMPING IN THE CONNECTOR. IT IS UNKNOWN WHETHER THE OPERATOR ENCOUNTERED EXCESSIVE PUMP PAUSES OR PRESSURE ALARMS, BOTH OF WHICH CAN CONTRIBUTE TO THE OCCURRENCE OF CLOTTING WITHIN THE DISPOSABLE SET. EXCESSIVE PUMP PAUSES, HISTORICALLY CAUSED BY ACCESS ISSUES, OR PUMP PAUSES OF AN EXTENDED TIME HAVE THE POTENTIAL TO RESULT IN COAGULATION IN THE ACCESS LINE, THIS NON-COAGULATED PORTION COULD THEN BE PULLED INTO THE SYSTEM VIA THE INLET LINE AND CONSEQUENTLY CLUMP TOGETHER, FULLY, OR PARTIALLY OCCLUDING THE DISPOSABLE SET. IF THE FILTER BECOMES COMPLETELY OCCLUDED, THE RESERVOIR CANNOT BE EMPTIED, AND THE RUN MUST BE DISCONTINUED. IT IS THEREFORE RECOMMENDED TO OPEN THE SALINE ROLLER CLAMPS IF THE PUMPS HAVE BEEN PAUSED FOR AN EXTENDED PERIOD OF TIME TO HELP CLEAR THE LINES. THE FOLLOWING ARE FURTHER POSSIBLE CAUSES OF CLOTTING WHICH COULD NOT BE RULED OUT AND INCLUDE: - INCORRECT ENTRY OF PATIENT DATA INCLUDING HCT AND PLATELET COUNTS - INCOMPLETE LOADING OF THE DISPOSABLE SET CAUSING AN OCCLUSION IN THE TUBING AND/OR AN AIR BLOCK, WHICH RESTRICTED THE FLOW - RBC DETECTOR CONTAINED AN AIR BUBBLE - DEFECTIVE DISPOSABLE SET CITATION: WEBB, C. B., LEVENO, M., QUINN, A. M., & BURNER, J. (2021). EFFECT OF TPE VS MEDICAL MANAGEMENT ON PATIENT OUTCOMES IN THE SETTING OF HYPERTRIGLYCERIDEMIA-INDUCED ACUTE PANCREATITIS WITH SEVERELY ELEVATED TRIGLYCERIDES. JOURNAL OF CLINICAL APHERESIS, 36(5), 719¿726. HTTPS://DOI.ORG/10.1002/JCA.21922.

    Description of Event or Problem · 0

    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 ONLY ONE TPE PROCEDURE, THE MEAN TG VALUES DECREASED FROM 4103 TO 1045 MG/DL (A REDUCTION OF 74.7%), AND THOSE RECEIVING TPE REACHED PLASMA TG 1000 MG/DL 0.99 DAYS FASTER THAN THE MEDICAL GROUP. ONE PATIENT IN THE TPE GROUP DIED. HOWEVER, WHEN EXCLUDING PATIENTS WITH HOSPITAL COURSES COMPLICATED BY MULTIPLE ORGAN DYSFUNCTION, THERE WAS NO SIGNIFICANT DIFFERENCE IN MORTALITY OR HOSPITAL LENGTH OF STAY (LOS) BETWEEN THE GROUPS. IN UNCOMPLICATED CASES OF HTG-AP WITH AN ABSENCE OF MULTIORGAN DYSFUNCTION, THERE IS NO SIGNIFICANT BENEFIT TO EITHER MORTALITY OR LOS WHEN ADDING ADJUNCT TPE TO MEDICAL MANAGEMENT, EVEN WHEN PATIENTS PRESENT WITH SEVERELY ELEVATED LEVELS OF TG. THREE PROCEDURES (16%) WERE ASSOCIATED WITH MILD HYPOTENSIVE EPISODES THAT RESOLVED WITH ADMINISTRATION OF NORMAL SALINE (NS). ONE PROCEDURE WAS ASSOCIATED WITH A CLOTTED LINE THAT WAS ADDRESSED WITH ALTEPLASE, AND ONE PATIENT EXPERIENCED MILD SYMPTOMS OF HYPOCALCEMIA SECONDARY TO CITRATE TOXICITY THAT IMPROVED WITH ORAL CALCIUM CARBONATE. 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. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    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 ONLY ONE TPE PROCEDURE, THE MEAN TG VALUES DECREASED FROM 4103 TO 1045 MG/DL (A REDUCTION OF 74.7%), AND THOSE RECEIVING TPE REACHED PLASMA TG < 1000 MG/DL 0.99 DAYS FASTER THAN THE MEDICAL GROUP. ONE PATIENT IN THE TPE GROUP DIED. HOWEVER, WHEN EXCLUDING PATIENTS WITH HOSPITAL COURSES COMPLICATED BY MULTIPLE ORGAN DYSFUNCTION, THERE WAS NO SIGNIFICANT DIFFERENCE IN MORTALITY OR HOSPITAL LENGTH OF STAY (LOS) BETWEEN THE GROUPS. IN UNCOMPLICATED CASES OF HTG-AP WITH AN ABSENCE OF MULTIORGAN DYSFUNCTION, THERE IS NO SIGNIFICANT BENEFIT TO EITHER MORTALITY OR LOS WHEN ADDING ADJUNCT TPE TO MEDICAL MANAGEMENT, EVEN WHEN PATIENTS PRESENT WITH SEVERELY ELEVATED LEVELS OF TG. THREE PROCEDURES (16%) WERE ASSOCIATED WITH MILD HYPOTENSIVE EPISODES THAT RESOLVED WITH ADMINISTRATION OF NORMAL SALINE (NS). ONE PROCEDURE WAS ASSOCIATED WITH A CLOTTED LINE THAT WAS ADDRESSED WITH ALTEPLASE, AND ONE PATIENT EXPERIENCED MILD SYMPTOMS OF HYPOCALCEMIA SECONDARY TO CITRATE TOXICITY THAT IMPROVED WITH ORAL CALCIUM CARBONATE. 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. SINCE THIS WAS A JOURNAL PUBLICATION OUTLINING A RETROSPECTIVE STUDY FOR PATIENT ADMISSIONS FOR HYPERTRIGLYCERIDEMIA-INDUCED ACUTE PANCREATITIS (HTG-AP) UNDER-GOING TPE PROCEDURES BETWEEN JANUARY 2014 AND JULY 2019 USING THE SPECTRA OPTIA® APHERESIS SYSTEM, A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. 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
    2265418 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O