BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 19921010 · Received August 6, 2024

    Report

    Report Number
    1722028-2024-00323
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    March 23, 2021
    Report Date
    August 6, 2024
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583122208
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. NOBLE, J., METZGER, A., BENNANI, H. N., DALIGAULT, M., MASSON, D., TERREC, F., IMERZOUKENE, F., BARDY, B., FIARD, G., MARLU, R., CHEVALLIER, E., JANBON, B., MALVEZZI, P., ROSTAING, L., & JOUVE, T. (2021). APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION. JOURNAL OF CLINICAL MEDICINE, 10(6), 1316. HTTPS://DOI.ORG/10.3390/JCM10061316.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION INVOLVING ALL ADULT PATIENTS THAT HAD UNDERGONE DESENSITIZATION FOR HLAI KT IN THE UNIVERSITY HOSPITAL OF GRENOBLE, SINCE JANUARY 2016, 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. SINCE THIS WAS A JOURNAL PUBLICATION TO ASSESS APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION INVOLVING ALL ADULT PATIENTS THAT HAD UNDERGONE DESENSITIZATION FOR HLAI KT IN THE UNIVERSITY HOSPITAL OF GRENOBLE, SINCE JANUARY 2016, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: STUDY POPULATION: IN THIS SINGLE-CENTER STUDY, ALL ADULT PATIENTS THAT HAD UNDERGONE DESENSITIZATION FOR HLAI KT IN THE UNIVERSITY HOSPITAL OF GRENOBLE, SINCE JANUARY 2016, WERE INCLUDED. PROCEDURES: APHERESIS SESSIONS WERE PERFORMED BY IA, PE, OR DFPP ACCORDING TO THE INITIAL MFI (S) OF DSA (S) FOR LIVING-DONOR KIDNEY-RECIPIENT KT OR ACCORDING TO THE IMMUNODOMINANT ANTI-HLA ALLOANTIBODY FOR A DECEASED DONOR¿S KT. PE OR DFPP WAS PERFORMED IF MFI WAS <6000 AND IA WAS PERFORMED IF MFI WAS >6000. PE WAS PERFORMED BY CENTRIFUGATION USING A SPECTRA OPTIA (BCT, LAKEWOOD, TERUMO, CO, USA) OR COMTEC (FRESENIUS KABI, FRANCE). DESENSITIZATION PROTOCOL: FOR LIVING-DONOR KT, THE PROTOCOL CONSISTED OF FOUR OR FIVE APHERESIS SESSIONS PER WEEK FOR 2 WEEKS PRIOR TO KT. IF THE DSA MFI WAS >12,000, IA WAS PERFORMED DAILY. IF DSA MFI WAS < 3000 BEFORE KT. KT WAS PERFORMED WHEN DSAS HAD AN MFI OF <3000, I.E., A NEGATIVE-FLOW CYTOMETRIC CROSSMATCH IN OUR CENTER ON THE DAY BEFORE KT. A SYSTEMATIC GRAFT BIOPSY WAS PERFORMED AT 1, 3 AND 12 MONTHS. FOR DECEASED-DONOR KT, THREE TO FIVE APHERESIS SESSIONS PER WEEK WERE CARRIED OUT UNTIL A COMPATIBLE KIDNEY GRAFT WAS AVAILABLE. IF NO NATIONALLY AVAILABLE GRAFT WAS PROPOSED WITHIN 45 DAYS AFTER STARTING DESENSITIZATION, THE FIRST LOCAL ABO-COMPATIBLE GRAFT, MATCHED FOR AGE AND WEIGHT, WAS PROPOSED. TO FACILITATE THE PURIFICATION OF HIGH MFIS HLA ANTIBODIES, SOME PATIENTS WITH HIGH LEVEL OF ANTIBODIES (MFI>12000) AND WAITING FOR A DECEASED DONOR WERE PRIMED BY RECEIVING TOCILIZUMAB INJECTIONS BEFORE THE START OF APHERESIS. STUDY POPULATION: BETWEEN AUGUST 2016 AND NOVEMBER 2020, 45 PATIENTS WERE DESENSITIZED IN THE SETTING OF HLAI KT AT GRENOBLE UNIVERSITY HOSPITAL. PATIENTS WERE AGED 53 ± 13 YEARS, AND 25 (55.6%) WERE WOMEN. MEAN BODY-MASS INDEX WAS 24 ± 4 KG/M2 . SEVENTEEN PATIENTS (44%) WERE DESENSITIZED IN THE SETTING OF A LIVING-DONOR HLAI KT. AMONG THESE, EIGHT WERE ALSO ABO INCOMPATIBLE. MEAN CPRA WAS 84.6 ± 26.3% (96 ± 5% FOR DECEASED DONORS AND 65 ± 35% FOR LIVING DONORS). A TOTAL OF TWENTY-THREE (59%) HAD UNDERGONE A PREVIOUS KT AND MEDIAN TIME ON DIALYSIS BEFORE DESENSITIZATION WAS 65 (16.5¿110) MONTHS. CHARACTERISTICS OF APHERESIS FOR HLAI KIDNEY TRANSPLANTATION: BETWEEN JANUARY 2016 AND JANUARY 2020, 881 APHERESIS SESSIONS WERE CARRIED OUT FOR THE 45 PATIENTS IN THE SETTING OF HLA-INCOMPATIBLE KT. THE NUMBER OF SESSIONS PER PATIENT WAS 15. IA WAS THE MOST PERFORMED TECHNIQUE WITH 720 (81.7%) SESSIONS. THE MEDIAN DURATION BETWEEN THE FIRST AND LAST SESSION FOR EACH PATIENT WAS 29 (15¿51) DAYS. THE MEDIAN DURATION OF ONE SESSION WAS 3.2 H (2.6¿3.9): IA SESSIONS TOOK SIGNIFICANTLY LONGER (3.5 ± 0.8 H) COMPARED TO DFPP (2.1 ± 0.6 H) AND PE (1.9 ± 0.6 H) (P < 0.001). EACH PATIENT HAD 9 ± 6 IA SESSIONS, 2 ± 1 PE SESSIONS, AND 3 ± 2 DFPP SESSIONS. THE MONET® FILTER WAS ADDED IN 340 IA SESSIONS (47.2%). A TOTAL OF THIRTEEN PATIENTS (28.9%) HAD RECEIVED AT LEAST ONE INJECTION OF TOCILIZUMAB PRIOR TO APHERESIS DESENSITIZATION AT A DOSE OF 8 MG/KG. A TOTAL OF NINETEEN (42.2%) PATIENTS RECEIVED IVIG INJECTIONS IN 47 IA SESSIONS (6.5%) AT THE DOSE OF 140 MG/KG, I.E., A MEAN DOSE OF 9.5 C 7 G FIBRINOGEN WAS INFUSED AFTER 51 SESSIONS AT A MEAN DOSE OF 1.8 +/- 0.8 G. CLINICAL TOLERANCE: SERIOUS ADVERSE EVENTS OCCURRED IN 17 (1.9%) SESSIONS AND HEMODYNAMIC INTOLERANCE OCCURRED IN 154 (17.5%) SESSIONS. WE ASSESSED THE ASSOCIATION OF SERIOUS ADVERSE EVENTS WITH AGE, TROUGH LEVEL OF TACROLIMUS, TECHNIQUE OF APHERESIS, RITUXIMAB, IVIG, TOCILIZUMAB, SIMULTANEOUS DIALYSIS, VASCULAR ACCESS, USE OF MEMBRANOUS FILTER, DURATION OF APHERESIS SESSION, ANTICOAGULATION AND BLOOD FLOW RATE. DFPP WAS SIGNIFICANTLY LESS WELL-TOLERATED COMPARED TO IA AND PE: SERIOUS ADVERSE EVENTS OCCURRED IN 6.5% OF DFPP SESSIONS VERSUS 1.9% AND 1.2% FOR PE AND IA, RESPECTIVELY (P < 0.01). TROUGH LEVEL OF TACROLIMUS WAS ALSO ASSOCIATED WITH SERIOUS ADVERSE EVENTS (P = 0.02). INTRASESSION HYPOTENSION OCCURRED IN 39.3% OF DFPP SESSIONS VERSUS 20.4% AND 14% FOR PE AND IA, RESPECTIVELY (P < 0.01). THE NUMBER OF SESSIONS WITH TECHNICAL ISSUES THAT REQUIRED A NURSE¿S INTERVENTION WAS 88 (10%) AND WAS SIMILAR BETWEEN THE THREE TECHNIQUES (P = 0.53). BIOLOGICAL TOLERANCE (TABLE 5): FIBRINOGEN DECREASED BY -46.7% (-23; -60) WITH A HIGHER LOSS WITH DFPP: -1.5% (-55; -69) VERSUS PE -33.3% (-28; -64) AND IA -42.9% (-22; -57) (P < 0.01). POST-SESSION FIBRINOGEN WAS LOWER WITH DFPP: 0.6 +/- 0.4 G/L COMPARED TO THE OTHER TECHNIQUES (1.0 +/ 0.7 G/L FOR IA AND 1.3 +/- 0.7 G/L FOR PE) (P < 0.01). FIVE (11.1%) PATIENTS PRESENTED WITH ASYMPTOMATIC CYTOMEGALOVIRUS (CMV) DNAEMIA AND 9 (20%) WITH EPSTEIN¿BARR VIRUS (EBV) DNAEMIA DURING THE DESENSITIZATION PERIOD. ONLY ONE PATIENT DEVELOPED CMV DISEASE WITH DIGESTIVE INVOLVEMENT. RED-BLOOD CELL TRANSFUSION WAS PERFORMED IN 82 (9.3%) SESSIONS. OVERALL, AUTHORS CONCLUDED THAT DESENSITIZATION WITH APHERESIS WAS EFFECTIVE AT REMOVING HLA ANTIBODIES AND ALLOWED ACCESS TO HLAI KT FOR SENSITIZED PATIENTS. IA AND EP WERE MORE EFFECTIVE TO REMOVE IGG AND ANTIHLA ANTIBODIES, ESPECIALLY FOR CLASS II DSAS, AND WERE BETTER TOLERATED THAN DFPP. 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. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, WHEN PLASMA IS EXCHANGED WITH A NON PLASMA REPLACEMENT SOLUTION, COAGULOPATHY CAUSED BY DILUTION OF COAGULATION FACTORS IS A POTENTIAL PROBLEM. THE PROTHROMBIN TIME AND ACTIVATED PARTIAL THROMBOPLASTIN TIME RISE AND FIBRINOGEN FALLS TO AN EXTENT RELATED TO THE INTENSITY OF THE EXCHANGE. DESPITE THESE HEMOSTATIC ALTERATIONS, HEMORRHAGIC COMPLICATIONS OF DILUTIONAL COAGULOPATHY ARE SELDOM ENCOUNTERED UNLESS A PATIENT IS HEMOSTATICALLY COMPROMISED BEFORE TREATMENT. ROUTINE SUPPLEMENTATION OF REPLACEMENT FLUIDS WITH PLASMA OR OTHER SOURCES OF CLOTTING FACTORS IS NOT RECOMMENDED FOR NONBLEEDING PATIENTS WHOSE BASELINE COAGULATION IS NORMAL. REDISTRIBUTION AND ONGOING SYNTHESIS RAISE LEVELS OF MOST COAGULATION FACTORS RAPIDLY IN THE HOURS FOLLOWING AN EXCHANGE. FIBRINOGEN IS USUALLY REPLACED MORE SLOWLY AND MIGHT BE CONSIDERED THE RATE-LIMITING FACTOR DETERMINING THE FREQUENCY OF PROCEDURES PERFORMED WITHOUT REPLACEMENT OF COAGULATION FACTORS. HOWEVER, THE PRODUCTION OF THIS ACUTE-PHASE PROTEIN VARIES GREATLY AMONG PATIENTS. FIBRINOGEN LEVELS MAY DECREASE SOMEWHAT BELOW 100 MG/DL IF SEVERAL PROCEDURES ARE PERFORMED ON CONSECUTIVE DAYS. A LEVEL NEAR 100 MG/ML IS GENERALLY SUFFICIENT FOR HEMOSTASIS UNLESS THE INDIVIDUAL HAS ANOTHER HEMOSTATIC CHALLENGE. IF FIBRINOGEN DECREASES A GREAT DEAL BELOW 100 MG/DL, SOME PHYSICIANS WILL THEN INCREASE THE INTERVAL BETWEEN PROCEDURES OR WILL USE PLASMA REPLACEMENT DURING THE LAST PART OF THE PROCEDURE TO AVOID A POTENTIAL BLEEDING DIATHESIS. FRESH FROZEN PLASMA (FFP) IS THE PREFERRED SOURCE OF FIBRINOGEN, AND IT SUPPLIES OTHER COAGULATION FACTORS AS WELL. FFP IS SELDOM REQUIRED, THOUGH, IF TPE IS PERFORMED AT INTERVALS OF 72 HOURS OR GREATER. HEMORRHAGE IS RARELY REPORTED IN PATIENTS UNDERGOING A TPE SERIES WITHOUT PLASMA REPLACEMENT IF THERE IS NO UNDERLYING PREDISPOSITION TO BLEEDING. 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, PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR HEMODYNAMIC STRESS OF THE PROCEDURE. POSSIBLE ROOT CAUSES FOR DECREASE IN FIBRINOGEN LEVELS THAT RESULTED IN FIBRINOGEN INFUSION INCLUDE BUT ARE NOT LIMITED TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW: * EXCHANGED WITH A NON-PLASMA REPLACEMENT SOLUTION RESULTING IN COAGULOPATHY CAUSED BY DILUTION OF COAGULATION FACTORS * LARGE VOLUME EXCHANGE CONDUCTED OVER A RELATIVELY SHORT PERIOD TREATMENT * LARGE VOLUME DEPLETION RESULTING IN COAGULOPATHY CAUSED BY REMOVAL OF CLOTTING FACTORS AND DILUTION OF COAGULATION FACTORS DUE TO LARGE VOLUME OF INFUSED ACDA * PATIENT WAS HEMOSTATICALLY COMPROMISED BEFORE TREATMENT CITATION: NOBLE, J., METZGER, A., BENNANI, H. N., DALIGAULT, M., MASSON, D., TERREC, F., IMERZOUKENE, F., BARDY, B., FIARD, G., MARLU, R., CHEVALLIER, E., JANBON, B., MALVEZZI, P., ROSTAING, L., & JOUVE, T. (2021). APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION. JOURNAL OF CLINICAL MEDICINE, 10(6), 1316. HTTPS://DOI.ORG/10.3390/JCM10061316.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE, "APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION" BY NOBLE, J., METZGER, A., BENNANI, H. N., DALIGAULT, M., MASSON, D., TERREC, F., IMERZOUKENE, F., BARDY, B., FIARD, G., MARLU, R., CHEVALLIER, E., JANBON, B., MALVEZZI, P., ROSTAING, L., & JOUVE, T. (2021), NEARLY 18% OF PATIENTS ON A WAITING LIST FOR KIDNEY TRANSPLANTATION (KT) ARE HIGHLY SENSITIZED, WHICH MAKE ACCESS TO KT MORE DIFFICULT. WE ASSESSED THE EFFICACY AND TOLERANCE OF DIFFERENT TECHNIQUES (PLASMA EXCHANGES [PE], DOUBLE-FILTRATION PLASMAPHERESIS [DFPP], AND IMMUNOADSORPTION [IA]) TO REMOVE DONOR SPECIFIC ANTIBODIES (DSA) IN THE SETTING OF HLA-INCOMPATIBLE (HLAI) KT. ALL PATIENTS THAT UNDERWENT APHERESIS FOR HLAI KT WITHIN A SINGLE CENTER WERE INCLUDED. INTRA-SESSION AND INTER-SESSION MEAN FLUORESCENCE INTENSITY (MFI) DECREASE IN DSA, CLINICAL AND BIOLOGICAL TOLERANCES WERE ASSESSED. A TOTAL OF 881 SESSIONS WERE PERFORMED FOR 45 PATIENTS: 107 DFPP, 54 PE, 720 IA. THE PROCEDURES LED TO HLAI KT IN 39 PATIENTS (87%) AFTER 29 (1551) DAYS. A HIGHER VOLUME OF TREATED PLASMA WAS ASSOCIATED WITH A GREATER DECREASE OF INTER-SESSION CLASS I AND II DSA (P = 0.04, P = 0.02). IA, PE, AND A LOWER MAXIMAL DSA MFI WERE ASSOCIATED WITH A GREATER DECREASE IN INTRA-SESSION CLASS II DSA (P 0.01). SAFETY WAS GOOD: SEVERE ADVERSE EVENTS OCCURRED IN 17 SESSIONS (1.9%), MORE FREQUENTLY WITH DFPP (6.5%) P 0.01. HYPOTENSION OCCURRED IN 154 SESSIONS (17.5%), MORE FREQUENTLY WITH DFPP (P 0.01). APHERESIS IS WELL TOLERATED (IA AND PE DFPP) AND EFFECTIVE AT REMOVING HLA ANTIBODIES AND ALLOWS HLAI KT FOR SENSITIZED PATIENTS. SERIOUS ADVERSE EVENTS OCCURRED IN 6.5% OF DFPP SESSIONS VERSUS 1.9% AND 1.2% FOR PE AND IA, RESPECTIVELY (P 0.01). TROUGH LEVELOF TACROLIMUS WAS ALSO ASSOCIATED WITH SERIOUS ADVERSE EVENTS (P= 0.02). INTRASESSION HYPOTENSION OCCURRED IN 39.3% OF DFPP SESSIONS VERSUS 20.4% AND 14% FOR PE AND IA,RESPECTIVELY (P 0.01). THE NUMBER OF SESSIONS WITH TECHNICAL ISSUES THAT REQUIRED A NURSES INTERVENTION WAS 88 (10%) AND WAS SIMILAR BETWEEN THE THREE TECHNIQUES (P= 0.53) 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 DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE, "APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION" BY NOBLE, J., METZGER, A., BENNANI, H. N., DALIGAULT, M., MASSON, D., TERREC, F., IMERZOUKENE, F., BARDY, B., FIARD, G., MARLU, R., CHEVALLIER, E., JANBON, B., MALVEZZI, P., ROSTAING, L., & JOUVE, T. (2021), NEARLY 18% OF PATIENTS ON A WAITING LIST FOR KIDNEY TRANSPLANTATION (KT) ARE HIGHLY SENSITIZED, WHICH MAKE ACCESS TO KT MORE DIFFICULT. WE ASSESSED THE EFFICACY AND TOLERANCE OF DIFFERENT TECHNIQUES (PLASMA EXCHANGES [PE], DOUBLE-FILTRATION PLASMAPHERESIS [DFPP], AND IMMUNOADSORPTION [IA]) TO REMOVE DONOR SPECIFIC ANTIBODIES (DSA) IN THE SETTING OF HLA-INCOMPATIBLE (HLAI) KT. ALL PATIENTS THAT UNDERWENT APHERESIS FOR HLAI KT WITHIN A SINGLE CENTER WERE INCLUDED. INTRA-SESSION AND INTER-SESSION MEAN FLUORESCENCE INTENSITY (MFI) DECREASE IN DSA, CLINICAL AND BIOLOGICAL TOLERANCES WERE ASSESSED. A TOTAL OF 881 SESSIONS WERE PERFORMED FOR 45 PATIENTS: 107 DFPP, 54 PE, 720 IA. THE PROCEDURES LED TO HLAI KT IN 39 PATIENTS (87%) AFTER 29 (15¿51) DAYS. A HIGHER VOLUME OF TREATED PLASMA WAS ASSOCIATED WITH A GREATER DECREASE OF INTER-SESSION CLASS I AND II DSA (P = 0.04, P = 0.02). IA, PE, AND A LOWER MAXIMAL DSA MFI WERE ASSOCIATED WITH A GREATER DECREASE IN INTRA-SESSION CLASS II DSA (P < 0.01). SAFETY WAS GOOD: SEVERE ADVERSE EVENTS OCCURRED IN 17 SESSIONS (1.9%), MORE FREQUENTLY WITH DFPP (6.5%) P < 0.01. HYPOTENSION OCCURRED IN 154 SESSIONS (17.5%), MORE FREQUENTLY WITH DFPP (P < 0.01). APHERESIS IS WELL TOLERATED (IA AND PE > DFPP) AND EFFECTIVE AT REMOVING HLA ANTIBODIES AND ALLOWS HLAI KT FOR SENSITIZED PATIENTS. SERIOUS ADVERSE EVENTS OCCURRED IN 6.5% OF DFPP SESSIONS VERSUS 1.9% AND 1.2% FOR PE AND IA, RESPECTIVELY (P< 0.01). TROUGH LEVEL OF TACROLIMUS WAS ALSO ASSOCIATED WITH SERIOUS ADVERSE EVENTS (P= 0.02). INTRASESSION HYPOTENSION OCCURRED IN 39.3% OF DFPP SESSIONS VERSUS 20.4% AND 14% FOR PE AND IA, RESPECTIVELY (P< 0.01). THE NUMBER OF SESSIONS WITH TECHNICAL ISSUES THAT REQUIRED A NURSE¿S INTERVENTION WAS 88 (10%) AND WAS SIMILAR BETWEEN THE THREE TECHNIQUES (P= 0.53) 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 WAS A JOURNAL PUBLICATION TO ASSESS APHERESIS EFFICACY AND TOLERANCE IN THE SETTING OF HLA-INCOMPATIBLE KIDNEY TRANSPLANTATION INVOLVING ALL ADULT PATIENTS THAT HAD UNDERGONE DESENSITIZATION FOR HLAI KT IN THE UNIVERSITY HOSPITAL OF GRENOBLE, SINCE JANUARY 2016. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. THE DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562857 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 05020583122208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other