SPECTRA OPTIA
Report
- Report Number
- 1722028-2024-00227
- Event Type
- Injury
- Date Received
- June 6, 2024
- Date of Event
- May 31, 2021
- Report Date
- June 6, 2024
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583102200
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: INTRODUCTION: FACTOR XI (FXI) DEFICIENCY IS A RARE CONGENITAL HEMOSTATIC DISORDER ASSOCIATED WITH INCREASED BLEEDING TENDENCY IN TRAUMA, SURGERY OR WHEN OTHER HEMOSTATIC DEFECTS ARE PRESENT. PERIOPERATIVE HEMOSTATIC MANAGEMENT OF A PATIENT WITH A SEVERE FXI DEFICIENCY UNDERGOING MAJOR ONCOLOGICAL LIVER AND COLORECTAL SURGERY WITH THERAPEUTIC PLASMA EXCHANGE (TPE) WITH FRESH FROZEN PLASMA (FFP) IS REPORTED. CASE DESCRIPTION: A 54-YEAR-OLD MALE WITH SEVERE FXI DEFICIENCY WAS SCHEDULED FOR RESECTION OF SYNCHRONOUS RECTAL CANCER AND MULTIPLE LIVER METASTASES. BASELINE PROTHROMBIN TIME (PT) WAS 97 %, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) 89 S(S) AND FXI LEVELS <1 IU/DL. THE ROTATIONAL THROMBOELASTOMETRY (ROTEM) PRESENTED A PROLONGED INTEM CLOTTING TIME (CT) = 443 S (RV 100 240 S) AND A CLOT FORMATION TIME (CFT) = 110 S (RV 30¿100 S). TPE WITH FFP WAS CARRIED OUT ACHIEVING FXI LEVELS UP TO 46 IU/DL AND AN APTT OF 33 S, NORMALIZING THROMBOELASTOMETRY PARAMETERS TO AN INTEM CT = 152 S AND A CFT = 86 S BEFORE THE PROCEDURE. AFTER SURGERY, THE PATIENT RECEIVED DAILY FFP TO MAINTAIN FXI LEVELS ABOVE 30 IU/DL UNTIL DISCHARGE ON THE EIGHTH DAY. A TOTAL OF 30 FFP UNITS WERE TRANSFUSED DURING HOSPITAL STAY. NO SIGNIFICANT BLEEDING EVENTS NEITHER TRANSFUSION RELATED COMPLICATIONS WERE OBSERVED DURING THE PERIOPERATIVE PERIOD. CONCLUSION: GIVEN THE LACK OF CORRELATION BETWEEN FXI LEVELS AND BLEEDING RISK, A MULTIDISCIPLINARY APPROACH BASED ON DAILY FXI LEVELS MONITORING, CLOSE CLINICAL ASSESSMENT AND FACTOR SUPPLEMENTATION IS MANDATORY. IN CONCLUSION, TPE WITH FFP IS AN EFFICACIOUS ALTERNATIVE STRATEGY TO CORRECT SEVERE FXI DEFICIENCY IN PATIENTS UNDERGOING MAJOR SURGERY. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: CASE REPORT A 54-YEAR-OLD WHITE MALE PATIENT DIAGNOSED WITH A RECTAL TUMOUR AND LIVER METASTASES WAS SCHEDULED FOR OPEN SURGICAL RESECTION. THE PATIENT HAS A SEVERE CONGENITAL FXI DEFICIENCY DISCOVERED DUE TO AN ABDOMINAL WALL HAEMATOMA AFTER A LAPAROSCOPIC CHOLECYSTECTOMY IN 1997 AT A DIFFERENT INSTITUTION. AT THAT MOMENT, THE BLEEDING COMPLICATION WAS TREATED WITH SEVERAL FFP UNITS ADMINISTRATION TO RAISE FXI LEVELS WITH NO TRANSFUSION RELATED ADVERSE EVENTS REPORTED. THE PATIENT DID NOT UNDERGO ANY OTHER INVASIVE PROCEDURE AFTER THIS EPISODE. NO OTHER PERSONAL NEITHER FAMILY BLEEDING HISTORY WAS REPORTED BY THE PATIENT. OTHER ANTECEDENTS INCLUDE ARTERIAL HYPERTENSION AND CHRONIC GASTRITIS TREATED WITH CANDESARTAN/HYDROCHLOROTHIAZIDE AND OMEPRAZOLE, RESPECTIVELY. PRIOR TO SURGERY, THE PATIENT RECEIVED 7 CYCLES OF CHEMOTHERAPY WITH FOLFOX, WITH NO RADIANT THERAPY. GIVEN THE GREAT EXTENT OF LIVER DISEASE, A TWO-STAGE SURGERY WAS PLANNED. FIRST, AN OPEN EXTENDED RIGHT HEPATECTOMY AND SECONDLY A HAND-ASSISTED LAPAROSCOPIC LOW ANTERIOR RECTUM RESECTION. BASELINE COAGULATION TESTS VALUES WERE PROTHROMBIN TIME (PT) OF 97%, APTT OF 89S (S) AND FXI LEVEL <1 IU/DL. THE APTT CORRECTED WITH THE ADDITION OF NORMAL PLASMA TO 32 S. THE REST OF COAGULATION FACTOR LEVELS WERE WITHIN NORMAL RANGE. WHOLE BLOOD VISCOELASTIC TEST BY THROMBOELASTOGRAPHY (TEG) AND ROTATIONAL THROMBOELASTOMETRY (ROTEM DELTA) WERE ALSO PERFORMED. TEG SHOWED A PROLONGED REACTION (R = 14 MIN) AND KINETIC TIME (K = 5 MIN) WITH NORMAL AMPLITUDE AND LYSIS PARAMETERS INDICATING A PROBABLE SLOWDOWN IN THROMBIN GENERATION. ALTERED ROTATIONAL THROMBOELASTOMETRY PARAMETERS BY ROTEM WERE INTEM CLOTTING TIME (CT) OF 443 S AND A CLOT FORMATION TIME (CFT) OF 110 S; THE REST OF THE VALUES AND ASSAYS WERE WITHIN NORMAL RANGE. (FIG. 1) EIGHTY PERCENT (80 %) OF THE THEORETICAL PATIENT¿S PLASMA VOLUME (2500 ML) WAS EXCHANGED 18 H BEFORE SURGERY USING TWO 18 GAUGE INTRAVENOUS PERIPHERAL ACCESS AND ANTICOAGULANT CITRATE DEXTROSE SOLUTION A (ACD-A) AS AN ANTICOAGULANT THROUGH AN OPTIA SPECTRA CONTINUOUS FLOW CELL SEPARATOR (TERUMO BCT) DURING 90 MIN AT A EXCHANGE RATE OF 35 ML/MIN. AT THE END OF THE PLASMAPHERESIS THE PATIENT PRESENTED SYMPTOMS OF HYPOCALCEMIA, WHICH WERE SUCCESSFULLY TREATED BY AN SLOWDOWN IN THE EXCHANGE RATE AND THE ADMINISTRATION OF 1 G OF CALCIUM GLUCONATE INTRAVENOUSLY. AFTER TPE, PREOPERATIVE APTT AND FXI LEVELS WERE 33 S AND 46 IU/DL, RESPECTIVELY. ROTATIONAL THROMBOELASTOMETRY INTEM AND EXTEM PARAMETERS WERE CORRECTED TO WITHIN NORMAL RANGE. TOTAL INTRAVENOUS ANESTHESIA TECHNIQUE GUIDED WITH BISPECTRAL INDEX (COVIDIEN, MEDTRONIC, USA) MONITORING WITH PROPOFOL-REMIFENTANIL TARGET CONTROL INFUSION WAS CHOSEN. ALSO 200 MICROGRAMS OF MORPHINE CHLORHYDRATE WERE ADMINISTERED INTRATHECALLY FOR POSTOPERATIVE ANALGESIA AT L4-L5 LEVEL WITH A 27-GAUGE PENCIL-POINT SPINAL NEEDLE IN A SINGLE ATTEMPT BY THE ANESTHESIOLOGIST. TRANEXAMIC ACID WAS CONTINUOUSLY INFUSED INTRAVENOUSLY AT A RATE OF 1 MILLIGRAM PER KILOGRAM PER HOUR WITH A TOTAL DOSE OF 500 MILLIGRAMS ADMINISTERED AT THE END OF THE PROCEDURE. LIVER SURGERY LASTED 4 H AND 51 MIN. ROTEM WAS USED TO MONITOR HEMOSTASIS INTRAOPERATIVELY IN THREE PHASES (FIG. 2). NO ABNORMAL BLEEDING EVENTS OCCURRED NEITHER TRANSFUSIONS WERE DEEMED NECESSARY DURING SURGERY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) UNDER MECHANICAL VENTILATORY SUPPORT WITH NO NEED OF VASOPRESSOR OR INOTROPIC THERAPY. THE SURGEONS NEITHER THE ANESTHESIOLOGIST REFERRED ANY ABNORMAL BLEEDING IN THE SURGICAL FIELD AT ANY TIME. THE IMMEDIATE POST-SURGICAL LABORATORY SHOWED AN APTT OF 38 S, FV LEVELS OF 79 IU/DL AND FXI LEVELS OF 32 IU/DL. TWO UNITS OF FFP WERE ADMINISTERED IMMEDIATELY ON ADMISSION TO ICU. DURING THE POSTOPERATIVE PERIOD DAILY CONTROL OF FXI LEVELS AND FFP TRANSFUSIONS TO MAINTAIN LEVELS ABOVE 30 IU/DL WERE APPLIED. THERE WERE NO COMPLICATIONS RELATED TO HEPATECTOMY. ENTERAL FEEDING WAS WELL TOLERATED ON THE SECOND POSTOPERATIVE DAY, SO THE PATIENT WAS DISCHARGED FROM ICU AND TRANSFERRED TO A GENERAL WARD. A DAILY AVERAGE OF FOUR FFP UNITS WERE ADMINISTERED DURING THE SIX DAYS FOLLOWING SURGERY WITH REGULAR APTT, FV AND FXI PLASMATIC DOSAGES. THE PATIENT WAS DISCHARGED HOME ON THE EIGHTH DAY WITH A HEMATOCRIT VALUE OF 29.1 %, APTT OF 34 S AND FXI LEVEL OF 40 IU/DL (TABLE 1). AFTER DISCHARGE, AMBULATORY FOLLOW-UP WITH LABORATORY CONTROL WAS PROGRAMMED. ONE MONTH AFTER DISCHARGE, THE PATIENT UNDERWENT A LABORATORY CONTROL SHOWING AN APTT OF 66 S AND FXI LEVEL OF 9 IU/DL. NO INTERVENTIONS WERE MADE AS THE PATIENT DID NOT MANIFEST ANY EVIDENCE OF CLINICAL BLEEDING. SIX MONTHS LATER, THE PATIENT WAS ADMITTED FOR THE SECOND SURGERY IN ORDER TO RESECT THE PRIMARY TUMOR IN THE RECTUM WITH NO HEMOSTATIC COMPLICATIONS REPORTED. INTRAOPERATIVE HEMOSTASIS WAS AGAIN MONITORED WITH ROTEM AS IN THE PREVIOUS SURGERY. LATER ON, THE PATIENT UNDERWENT TWO OTHER MINOR INTERVENTIONS, AN ILEOSTOMY CLOSURE AND AN ABDOMINAL WALL EVENTRATION REPAIRMENT. A SIMILAR STRATEGY OF PREOPERATIVE TPE AND FFP TRANSFUSION DURING THE POSTSURGICAL PERIOD TO MAINTAIN ADEQUATE FXI LEVELS WAS IMPLEMENTED THROUGHOUT ALL THE BEFORE MENTIONED PROCEDURES AND NO BLEEDING EVENTS OR OTHER COMPLICATIONS WERE OBSERVED. HOWEVER, GIVEN THE LOWER RISK OF BLEEDING, NO VISCOELASTIC TEST MONITORING WAS USED IN THE LAST TWO OF THEM. 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. SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS MANAGEMENT OF FACTOR XI DEFICIENCY IN ONCOLOGICAL LIVER AND COLORECTAL SURGERY BY THERAPEUTIC PLASMA EXCHANGE, 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 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 PATIENT 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. PRATX, L. B., SANTORO, D., MILEO, F., MARTINUZZO, M., ARDILES, V., DE SANTIBAÑES, E., & SALAMONE, H. (2021). MANAGEMENT OF FACTOR XI DEFICIENCY IN ONCOLOGICAL LIVER AND COLORECTAL SURGERY BY THERAPEUTIC PLASMA EXCHANGE: A CASE REPORT. TRANSFUSION AND APHERESIS SCIENCE, 60(5), 103176. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2021.103176.
LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED. PRATX, L. B., SANTORO, D., MILEO, F., MARTINUZZO, M., ARDILES, V., DE SANTIBAÑES, E., & SALAMONE, H. (2021). MANAGEMENT OF FACTOR XI DEFICIENCY IN ONCOLOGICAL LIVER AND COLORECTAL SURGERY BY THERAPEUTIC PLASMA EXCHANGE: A CASE REPORT. TRANSFUSION AND APHERESIS SCIENCE, 60(5), 103176. HTTPS://DOI.ORG/10.1016/J.TRANSCI.2021.103176.
PER JOURNAL ARTICLE "MANAGEMENT OF FACTOR XI DEFICIENCY IN ONCOLOGICAL LIVER AND COLORECTAL SURGERY BY THERAPEUTIC PLASMA EXCHANGE: A CASE REPORT", BY BURGOS PRATX, L. D., SANTORO, D. M., MILEO, F. G., MARTINUZZO, M. E., ARDILES, V., E SANTIBAÑES, E., SALAMONE, H. J.. A 54-YEAR-OLD MALE WITH SEVERE FXI DEFICIENCY WAS SCHEDULED FOR RESECTION OF SYNCHRONOUS RECTAL CANCER AND MULTIPLE LIVER METASTASES. BASELINE PROTHROMBIN TIME (PT) WAS 97 %, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) 89 S(S) AND FXI LEVELS <1 IU/DL. THE ROTATIONAL THROMBOELASTOMETRY (ROTEM¿) PRESENTED A PROLONGED INTEM CLOTTING TIME (CT) = 443 S (RV 100- 240 S) AND A CLOT FORMATION TIME (CFT) = 110 S (RV 30¿100 S). TPE WITH FFP WAS CARRIED OUT ACHIEVING FXI LEVELS UP TO 46 IU/ DL AND AN APTT OF 33 S, NORMALIZING THROMBOELASTOMETRY PARAMETERS TO AN INTEM CT = 152 S AND A CFT = 86 S BEFORE THE PROCEDURE. AFTER SURGERY, THE PATIENT RECEIVED DAILY FFP TO MAINTAIN FXI LEVELS ABOVE 30 IU/DL UNTIL DISCHARGE ON THE EIGHTH DAY. A TOTAL OF 30 FFP UNITS WERE TRANSFUSED DURING HOSPITAL STAY. NO SIGNIFICANT BLEEDING EVENTS NEITHER TRANSFUSION RELATED COMPLICATIONS WERE OBSERVED DURING THE PERIOPERATIVE PERIOD. AT THE END OF THE PLASMAPHERESIS THE PATIENT PRESENTED SYMPTOMS OF HYPOCALCEMIA, WHICH WERE SUCCESSFULLY TREATED BY AN SLOWDOWN IN THE EXCHANGE RATE AND THE ADMINISTRATION OF 1 G OF CALCIUM GLUCONATE INTRAVENOUSLY. AFTER TPE, PREOPERATIVE APTT AND FXI LEVELS WERE 33 S AND 46 IU/DL, RESPECTIVELY. ROTATIONAL THROMBOELASTOMETRY INTEM AND EXTEM PARAMETERS WERE CORRECTED TO WITHIN NORMAL RANGE. PATIENT ID AND WEIGHT ARE UNKNOWN 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.
PER JOURNAL ARTICLE "MANAGEMENT OF FACTOR XI DEFICIENCY IN ONCOLOGICAL LIVER AND COLORECTAL SURGERY BY THERAPEUTIC PLASMA EXCHANGE: A CASE REPORT", BY BURGOS PRATX, L. D., SANTORO, D. M., MILEO, F. G., MARTINUZZO, M. E., ARDILES, V., E SANTIBAÑES, E., SALAMONE, H. J.. : A 54-YEAR-OLD MALE WITH SEVERE FXI DEFICIENCY WAS SCHEDULED FOR RESECTION OF SYNCHRONOUS RECTAL CANCER AND MULTIPLE LIVER METASTASES. BASELINE PROTHROMBIN TIME (PT) WAS 97 %, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) 89 S(S) AND FXI LEVELS <1 IU/DL. THE ROTATIONAL THROMBOELASTOMETRY (ROTEM¿) PRESENTED A PROLONGED INTEM CLOTTING TIME (CT) = 443 S (RV 100- 240 S) AND A CLOT FORMATION TIME (CFT) = 110 S (RV 30¿100 S). TPE WITH FFP WAS CARRIED OUT ACHIEVING FXI LEVELS UP TO 46 IU/ DL AND AN APTT OF 33 S, NORMALIZING THROMBOELASTOMETRY PARAMETERS TO AN INTEM CT = 152 S AND A CFT = 86 S BEFORE THE PROCEDURE. AFTER SURGERY, THE PATIENT RECEIVED DAILY FFP TO MAINTAIN FXI LEVELS ABOVE 30 IU/DL UNTIL DISCHARGE ON THE EIGHTH DAY. A TOTAL OF 30 FFP UNITS WERE TRANSFUSED DURING HOSPITAL STAY. NO SIGNIFICANT BLEEDING EVENTS NEITHER TRANSFUSION RELATED COMPLICATIONS WERE OBSERVED DURING THE PERIOPERATIVE PERIOD. AT THE END OF THE PLASMAPHERESIS THE PATIENT PRESENTED SYMPTOMS OF HYPOCALCEMIA, WHICH WERE SUCCESSFULLY TREATED BY AN SLOWDOWN IN THE EXCHANGE RATE AND THE ADMINISTRATION OF 1 G OF CALCIUM GLUCONATE INTRAVENOUSLY. AFTER TPE, PREOPERATIVE APTT AND FXI LEVELS WERE 33 S AND 46 IU/DL, RESPECTIVELY. ROTATIONAL THROMBOELASTOMETRY INTEM AND EXTEM PARAMETERS WERE CORRECTED TO WITHIN NORMAL RANGE. PATIENT ID AND WEIGHT ARE UNKNOWN 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 |
|---|---|---|---|---|---|---|---|
| 2244905 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 05020583102200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | Other |