COBE SPECTRA BLOOD COLLECTION
Report
- Report Number
- 1722028-2020-00181
- Event Type
- Injury
- Date Received
- April 24, 2020
- Date of Event
- February 6, 2016
- Report Date
- April 24, 2020
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- UDI-DI
- 05020583706200
- PMA / PMN Number
- BK080035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: THIS WAS A RETROSPECTIVE STUDY INVOLVING SIXTY-TWO PEDIATRIC PATIENTS RANGING IN AGE FROM 1 TO 17 YEARS OF AGE, WITH A MEDIAN AGE OF 4.5 YEARS. NO. PATIENTS 62 SEX (M/F) 30/32 MEDIAN AGE, YEARS (%) 4.5 (RANGE, 1217) < OR EQUAL 3 YEARS 27 (44%) >4 YEARS 35 (56%) MEDIAN WEIGHT (%) 18 (RANGE, 8-103) <10 KG 6 (10%) 10220 KG 30 (48%) 20240 KG 10 (16%) 40260 KG 8 (13%) >60 KG 8 (13%) AS A COMPARISON GROUP, AE WERE ALSO EXAMINED IN 82 ADULT MULTIPLE MYELOMA PATIENTS WHO UNDERWENT 210 A-HPCC DURING THE 2013 CALENDAR YEAR. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE. SINCE THIS WAS A RETROSPECTIVE REVIEW OF PROSPECTIVELY-COLLECTED, PROCEDURE-RELATED AE DURING HPCC AT THE UNIVERSITY OF MICHIGAN BETWEEN 4/2009 AND 12/2013, THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. SIDE EFFECTS DUE TO CITRATE ANTICOAGULANT WERE NOTED IN 25% OF PATIENTS (14/56) AND 14% (15/106) OF PROCEDURES. SEVERE AE (5.4% PATIENTS) WERE LIMITED TO GASTROINTESTINAL SYMPTOMS: NO HYPOTENSION OR TETANY WERE NOTED. GASTROINTESTINAL SYMPTOMS COMPOSED THE MAJORITY OF AE (75%, 9/14) AND INCLUDED ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA. NEUROLOGIC SYMPTOMS WERE RECORDED IN 7 (12%) PATIENTS AND INCLUDED PARASTHESIAS, LIGHTHEADEDNESS, AND AGITATION. AGITATION OCCURRED IN ONE CHILD IN THREE SUCCESSIVE COLLECTIONS. COLLECTIONS WITHIN 30 MIN OF STARTING CELL COLLECTION. NEUROLOGIC SYMPTOMS, INCLUDING AGITATION, WERE MILD AND RESPONSIVE TO INCREASING THE CALCIUM REPLACEMENT INFUSION RATE. A TOTAL OF 18 VENOUS AE WERE DOCUMENTED IN 13 PROCEDURES (12%) AND 19% (12/62) OF PATIENTS (TABLE IV). SIX PATIENTS HAD MORE THAN ONE DOCUMENTED AE PER PROCEDURE. SIX AE WERE MILD (33%), 7 WERE MODERATE (39%), AND 5 SEVERE (28%). VENOUS AE INCLUDED BLEEDING, PAIN; OCCLUDED CVC REQUIRING MULTIPLE FLUSHES THROUGHOUT THE PROCEDURE, REVERSAL OF ARTERIAL AND VENOUS LINES, PIV FOR DRAW, OR POSITIONAL MANEUVERS; MULTIPLE VENIPUNCTURES, AND PROCEDURE CANCELLED OR TERMINATED EARLY DUE TO ACCESS ISSUES. ONE PATIENT LOST A PIV MIDWAY THROUGH THE PROCEDURE AND REQUIRED SEVERAL ATTEMPTS TO RE-ESTABLISH VENOUS ACCESS. TWO PATIENTS WITH POORLY FUNCTIONING CVCS REQUIRED PLACEMENT OF A PIV FOR DRAW (N=1) OR RETURN (N=1). LIKE PEDIATRIC ALLOGENIC DONORS, BLEEDING AND PAIN WERE USUALLY ASSOCIATED WITH NEWLY PLACED CVC AND TENDED TO OCCUR IN YOUNGER PATIENTS (MEDIAN 5.5 YEARS). BLEEDING WAS MINIMAL AND LIMITED TO OOZING AROUND THE INSERTION SITE AND RESPONDED TO PRESSURE (N=1) OR A TOPICAL CLOTTING AGENT (N=1). NO PATIENT REQUIRED A BLOOD TRANSFUSION FOR CATHETER-RELATED BLOOD LOSS. MILD PAIN WAS TREATED WITH ACETOMINOPHEN IN TWO PATIENTS: ONE PATIENT REQUIRED MORPHINE FOR PAIN RELIEF. TWENTY-TWO MODERATE TO SEVERE TECHNICAL AE WERE DOCUMENTED IN 7 PATIENTS (11%) AND 9 PROCEDURES (8%). AE INCLUDED SLOW INLET RATES, MULTIPLE ALARMS, AN UNSTABLE INTERFACE, PROLONGED PROCEDURE TIMES, CLOTTED CIRCUIT WITH BLOOD LOSS, AND PREMATURE TERMINATION OF THE PROCEDURE (TABLE IV, SUPPORTING INFORMATION TABLE S1). MOST AE (8/9) WERE DUE TO POORLY FUNCTIONING CVCS. IN PATIENTS WITH NEWLY PLACED FEMORAL LINES, CATHETER-RELATED ISSUES WERE ENCOUNTERED AFTER DAY 1. IN ONE OLDER PATIENT, POOR CVC FUNCTION WAS ATTRIBUTED TO PLACEMENT OF A LEFT SUBCLAVIAN CVC THAT WAS TOO SMALL FOR HER AGE AND SIZE. PROLONGED PROCEDURE TIMES OCCURRED IN 66% (6/9) OF AFFECTED PROCEDURES. IN FOUR PROCEDURES, INLET RATES WERE <1 ML/KG/MINUTE (RANGE, 0.31-0.72; SUPPORTING INFORMATION TABLE S1). IN ONE PATIENT, PROLONGED PROCEDURE TIMES WERE DUE TO A LONG DELAY IN ESTABLISHING THE INTERFACE FOLLOWING A RBC PRIME. IN GENERAL, TECHNICAL AE INCREASED PROCEDURE TIME BY 35 MIN (RANGE, 8¿105 MIN) RELATIVE TO CASE-MATCHED CONTROLS (TBV65%). DUE TO SLOW INLET RATES, THREE PROCEDURES DID NOT ACHIEVE A FULL LVL COLLECTION. PROLONGED PROCEDURE TIMES MAY HAVE CONTRIBUTED TO CITRATE AE IN TWO PATIENTS. ONE PATIENT HAD A MILD ALLERGIC REACTION TO THE RBC PRIME. SYMPTOMS WERE LIMITED TO PRURITIS AND RASH AND RESPONDED TO ADDITIONAL ANTIHISTAMINES. NO PATIENT HAD HYPOTENSION OR HEMODYNAMIC INSTABILITY. COMPARISON OF AE IN PEDIATRICS AND ADULTS PEDIATRIC ALLOGENEIC DONORS ARE REPORTED TO HAVE LESS AE THAN ADULTS DUE, IN LARGE PART, TO SIGNIFICANTLY LESS G-CSF TOXICITY. TO DETERMINE WHETHER THE SAME WAS TRUE FOR A-HPCC, WE COMPARED PROCEDURE-RELATED AE IN PEDIATRIC PATIENTS TO 82 ADULT MYELOMA PATIENTS WHO UNDERWENT A TOTAL OF 210 A-HPCC DURING THE 2013 CALENDAR YEAR. OVERALL, AE WERE SLIGHTLY MORE FREQUENT IN ADULT PATIENTS (48% VS. 39%) ALTHOUGH THE AE RATE PER PROCEDURE WAS IDENTICAL (~25%, TABLE IV). THERE WAS NO SIGNIFICANT DIFFERENCE IN CITRATE RELATED AE BETWEEN CHILDREN AND ADULTS. CHILDREN, HOWEVER, WERE THREE TIMES MORE LIKELY TO EXPERIENCE GASTROINTESTINAL SYMPTOMS (16% VS. 9%, OR=3.38) WHEREAS PARASTHESIAS WERE COMMON IN ADULTS (31% VS.9%, P=0.002). CHILDREN WERE ALSO MORE LIKELY TO HAVE TECHNICAL PROBLEMS DUE TO CVC-RELATED ISSUES (85.7%, P=0.006). UNLIKE PEDIATRIC PATIENTS, MOST ADULT PATIENTS WERE COLLECTED USING PIV (75.6%, P<0.00001). MOST ALARMS IN ADULTS WERE ATTRIBUTED TO SLOW INLET FLOW, HIGH RETURN PRESSURES OR MACHINE OBSTRUCTIONS/MALFUNCTIONS ASSOCIATED WITH A NEW BLOOD SEPARATOR. THEY ALSO EXAMINED THE IMPACT OF AE ON CD34 COLLECTION AND HPC PRODUCT QUALITY. TECHNICAL AE DUE TO FLOW PROBLEMS HAVE THE POTENTIAL TO INTERFERE WITH A STABLE INTERFACE. FURTHERMORE, REVERSAL OF ARTERIAL AND VENOUS LINES USING DUAL LUMEN CATHETERS IS REPORTED TO INCREASE RECIRCULATION BY 7% TO 20%, WITH DECREASES IN CD34-CE [17,31,32]. FINALLY, MULTIPLE VENIPUNCTURES, REPEATED LINE FLUSHING AND MANIPULATION COULD INCREASE THE RISK FOR BACTERIAL CONTAMINATION. WHEN EXAMINED BY SPECIFIC TYPE OF AE, PRODUCTS ASSOCIATED WITH TECHNICAL AE TENDED TO HAVE LOWER CD34 YIELDS (4.2 VS.21.6 MILLION/KG, P=0.00035) DUE TO LOWER PERIPHERAL CD34 COUNTS AND A HIGH NUMBER OF ABORTED PROCEDURES (3/8, 37%). THERE WERE NO POSITIVE CULTURES WITH ANY PRODUCT COLLECTED. THE AUTHORS FOUND THAT OLDER AND HEAVIER CHILDREN HAD THE HIGHEST AE RATES, REACHING 56% IN CHILDREN>40 KG (FIG. 1). OLDER CHILDREN WERE ALSO MORE LIKELY TO HAVE MORE PROCEDURES, INCREASING THE LIKELIHOOD FOR PROCEDURE-ASSOCIATED AE (TABLE III). THEY DID NOT OBSERVE CITRATE OR OTHER AE IN CHILDREN LESS THAN 10 KG, WHO WERE SYSTEMICALLY ANTICOAGULATED WITH HEPARIN. A MARKED REDUCTION IN CITRATE AE IS ALSO REPORTED USING LOW DOSE-CITRATE AND HEPARIN ANTICOAGULANT REGIMENS (10 UNITS/ML HEPARIN IN ACD-A). DISADVANTAGES OF HEPARIN ARE GREATER PROCEDURAL PLATELET LOSSES, PROLONGED COAGULATION ABNORMALITIES, BLEEDING, AND POTENTIAL HEPARIN SENSITIZATION. THE AUTHORS RECORDED TECHNICAL AE IN 7 PATIENTS (11.3%) AND 9 PROCEDURES (8%). UNLIKE ADULT PATIENTS, TECHNICAL AE IN PEDIATRIC PATIENTS WERE OVERWHELMING CVC-RELATED (85.7%, P=0.002), LEADING TO INTERFACE DELAYS, PROLONGED PROCEDURES AND/ OR SHORT COLLECTIONS. THEY OBSERVED ONE SEVERE TECHNICAL AE DUE TO CLOTTING OF THE CIRCUIT. TECHNICAL AE DUE TO INSTRUMENTATION AND CIRCUIT LOSS TEND TO BE SEVERE, OFTEN LEADING TO ABORTED PROCEDURES, BLOOD LOSS AND POTENTIALLY PRODUCT LOSS. MOST TECHNICAL AE WERE CVC-RELATED, REQUIRING REVERSAL OF LINES OR "EXTREME POSITIONAL MANEUVERS" TO COMPLETE THE PROCEDURE. IN CONTRAST, CVC-RELATED TECHNICAL AE WERE SIGNIFICANTLY LESS COMMON IN THEIR ADULT PATIENTS, WHO ARE ROUTINELY COLLECTED BY PIV WHENEVER POSSIBLE. IN A RECENT STUDY, ALARMS DUE TO A SLOW INLET FLOW RATE OCCURRED IN ONLY 0.69% OF ADULT A-HPCC. THE HIGH FREQUENCY OF CVC-RELATED TECHNICAL AE IN OUR PEDIATRIC PATIENTS REFLECTS THE DIFFICULTY AND IMPORTANCE OF ESTABLISHING ADEQUATE VENOUS ACCESS IN THIS POPULATION. IN ONE OF THEIR PATIENTS, THE CATHETER (9 FRENCH) WAS CLEARLY TOO SMALL FOR THE PATIENT¿S AGE AND WEIGHT (68 KG). FOUR OF THEIR PATIENTS HAD A LEFT SIDED SUBCLAVIAN CVC, WITH LINE-RELATED AE DOCUMENTED IN 2 PATIENTS AND 3 PROCEDURES, AND DECREASED CD34-CE (40% VS. 58%, P=0.03). LEFT-SIDED SUBCLAVIAN CVC HAVE A DOCUMENTED HIGHER RATE OF MALFUNCTION, INCLUDING HPCC. THEY HAVE REPORTED A 19% SEVERE AE RATE WITH LEFT-SIDED CVC IN ADULT A-HPCC. PATIENTS UNDERGOING A-HPCC MAY BE AT HIGHER RISK FOR CVC OCCLUSION, IN GENERAL, DUE TO G-CSF¿S PROTHROMBOTIC EFFECTS ON PLATELET REACTIVITY AND COAGULATION FACTORS. PROPHYLACTIC CALCIUM GLUCONATE INFUSION THROUGH THE RETURN LINE MAY ALSO INCREASE THE RISK FOR CATHETER MALFUNCTION. ONE PEDIATRIC PATIENT DEVELOPED A MILD ALLERGIC REACTION TO THE RBC PRIME UNIT. SYMPTOMS WERE LIMITED TO PRURITIS AND RASH AND THE PATIENT RESPONDED TO ADDITIONAL ANTIHISTAMINES. ACCORDING TO THE AABB CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD COMPONENTS (REVISED 2017), ALLERGIC REACTIONS FREQUENTLY OCCUR (IE, 1-3% OF PLASMA-CONTAINING COMPONENTS) AS MILD OR SELF-LIMITING URTICARIA OR WHEEZING THAT USUALLY RESPOND TO ANTIHISTAMINES. MORE SEVERE MANIFESTATIONS, INCLUDING RESPIRATORY AND CARDIOVASCULAR SYMPTOMS, ARE MORE CONSISTENT WITH ANAPHYLACTOID/ANAPHYLACTIC REACTIONS AND MAY REQUIRE MORE AGGRESSIVE THERAPY. NO LABORATORY PROCEDURES ARE AVAILABLE TO PREDICT THESE REACTIONS. 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. THE OPTIA ESSENTIALS GUIDE ADVISES THE OPERATOR OF POSSIBLE ADVERSE EFFECTS OF APHERESIS PROCEDURES AND TO BE PREPARED TO TAKE APPROPRIATE ACTION SHOULD ANY REACTIONS OCCUR. SOME PREVIOUSLY REPORTED REACTIONS ARE: ANXIETY, HEADACHE, LIGHT-HEADEDNESS, DIGIT AND/OR FACIAL PARESTHESIA, FEVER, CHILLS, HEMATOMA, HYPERVENTILATION, NAUSEA AND VOMITING, SYNCOPE (FAINTING), URTICARIA, HYPOTENSION, ALLERGIC REACTIONS ONE PEDIATRIC PATIENT DEVELOPED PAIN WITH NEWLY PLACED CVC AND REQUIRED MORPHINE FOR PAIN RELIEF. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, A CENTRAL VENOUS CATHETER (CVC) REPRESENTS THE SINGLE GREATEST RISK FACTOR FOR ADVERSE EVENTS ASSOCIATED WITH THERAPEUTIC APHERESIS, AND IT SHOULD BE AVOIDED WHENEVER POSSIBLE. ROOT CAUSE: THE AUTHORS ATTRIBUTED THE MILD ALLERGIC REACTION TO THE RBC PRIME UNIT, AND THE PAIN THE OTHER PATIENT EXPERIENCED TO THE NEWLY PLACED CVC. A DEFINITIVE ROOT CAUSE FOR THE REPORTED CITRATE REACTIONS COULD NOT BE DETERMINED. 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. POSSIBLE CAUSES FOR MINOR BLEEDING AT THE INSERTION SITE OF THE CENTRAL VENOUS CATHETER INCLUDE BUT ARE NOT LIMITED TO: ISSUES WITH THE CVC ACCESS RAPID RETURN FLOWS IN SOME PROCEDURES CAN CAUSE LEAKAGE OF BLOOD FROM THE VESSELS INTO THE SURROUNDING TISSUE. THE AUTHORS STATED THAT MOST ACCESS ISSUES "WERE DUE TO POORLY FUNCTIONING CVCS. IN PATIENTS WITH NEWLY PLACED FEMORAL LINES, CATHETER-RELATED ISSUES WERE ENCOUNTERED AFTER DAY 1. IN ONE OLDER PATIENT, POOR CVC FUNCTION WAS ATTRIBUTED TO PLACEMENT OF A LEFT SUBCLAVIAN CVC THAT WAS TOO SMALL FOR HER AGE AND SIZE." A DEFINITIVE ROOT CAUSE FOR PERFORMANCE ISSUES COULD NOT BE DETERMINED. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO: SLOW INLET RATES DUE TO ISSUES WITH THE PATIENTS' ACCESSES UNSTABLE INTERFACE DUE TO BLOOD PRIME AND/OR SLOW INLET FLOW RATES SLOW INLET FLOW RATES RESULTED IN PROLONGED PROCEDURE TIMES CLOTTING DUE TO IMPROPER ANTICOAGULATION OF THE EXTRACORPOREAL CIRCUIT CLOTTED CIRCUIT AND/OR PROPHYLACTIC ADMINISTRATION OF CALCIUM GLUCONATE BLOOD LOSS DUE TO PREMATURE TERMINATION OF THE PROCEDURE.
LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: PER THE ARTICLE, MOST PATIENTS UNDERWENT SHORT-TERM, DOUBLE LUMEN CENTRAL VENOUS CATHETER (CVC) PLACEMENT THE MORNING OF THEIR FIRST A-HPCC. FOLLOWING EACH APHERESIS SESSION, THE CATHETER PORTS WERE FLUSHED INITIALLY WITH 5 ML SALINE, FOLLOWED BY HEPARIN (1:1000 UNITS/ML, 0.9-1.3 ML FILL VOLUME) AND THEN CAPPED. FEMORAL AND OTHER NON-TUNNELED CATHETERS WERE REMOVED WITHIN 24 HOURS OF THE LAST A-HPCC. ALL PATIENTS UNDERWENT LARGE VOLUME LEUKAPHERESIS (LVL) BY CONTINUOUS-FLOW CENTRIFUGATION (COBE SPECTRA) USING THE WBC COLLECTION SET. A TOTAL OF 3 TBV WERE PROCESSED PER PROCEDURE. MNCS WERE COLLECTED AT A BLOOD PLASMA INTERFACE OF 1% TO 2% HEMATOCRIT, A MEAN INLET VOLUME OF 1 ML/KG/MINUTE, AND A COLLECTION VOLUME OF 1.0 ML/MINUTE. FOR PATIENTS WEIGHING <10 KG BODY WEIGHT, A-HPCC WAS PERFORMED IN THE PEDIATRIC INTENSIVE CARE UNIT, USING A RECONSTITUTED WHOLE BLOOD PRIME AND SYSTEMIC HEPARIN ANTICOAGULATION (30 UNITS/KG). HEPARIN WAS MONITORED BY THE ACTIVATED CLOTTING TIME (THERAPEUTIC RANGE, 180¿220 S). TO PREVENT CLOTTING OF THE PRODUCT, ACD-A WAS MANUALLY ADDED TO THE FINAL PRODUCT (10% FINAL PRODUCT VOLUME). PATIENTS WEIGHING >10 KG WERE ANTICOAGULATED WITH ACD-A AT AN ANTICOAGULANT: WHOLE BLOOD (AC:WB) RATIO OF 1:12. TO MITIGATE AGAINST DILUTIONAL ANEMIA AND HYPOTENSION, A RBC PRIME WAS USED IF THE EXTRACORPOREAL VOLUME WAS > 10% OF THE PATIENT¿S TOTAL BLOOD VOLUME. PATIENTS RECEIVED PROPHYLACTIC CALCIUM GLUCONATE (3%, 22.6 MG/ML IN 100 ML NORMAL SALINE) ON A WEIGHT-BASED SCALE RANGE TO PREVENT CITRATE TOXICITY, WHERE FLOW RATE RANGE=[(PATIENT WEIGHT IN KG] X (30 TO 90 MG/ML)] / 22.6 MG/ML CALCIUM GLUCONATE SOLUTION / 3 HOURS (APPROXIMATE TOTAL INFUSION TIME). RBC FOR MACHINE PRIMING WERE ABO/RH COMPATIBLE, PRE-STORAGE LEUKOREDUCED, AND IRRADIATED. PATIENTS WHO REQUIRED A BLOOD PRIME WERE PREMEDICATED WITH ANTIHISTAMINE AND ACETAMINOPHEN. TO AVOID VOLUME OVERLOAD, NO RINSE-BACK WAS PERFORMED AT THE END OF THE PROCEDURE. AE WERE ALSO GRADED AS MILD, MODERATE OR SEVERE. A TOTAL OF 55 INDIVIDUAL AE WERE DOCUMENTED IN 24 CHILDREN AND 27 PROCEDURES (24.5%). THE MAJORITY OF AE WERE GRADED AS MODERATE (54.5%) OR SEVERE (27.3%). MOST SEVERE AE (73%) WERE TECHNICAL AND VENOUS ACCESS. PATIENTS REQUIRING MORE THAN ONE PROCEDURE WERE MORE LIKELY TO EXPERIENCE AT LEAST ONE AE OVER THE COURSE OF TREATMENT (58% VS. 27%, P=0.012). IN GENERAL, AE TENDED TO BE MORE COMMON IN OLDER AND LARGER CHILDREN, WHO WERE ALSO MORE LIKELY TO REQUIRE SEVERAL PROCEDURES (FIG. 1, P=0.07). WHEN EXAMINED BY DIAGNOSIS, AE WERE ALSO HIGHER IN CHILDREN WITH "OTHER" DIAGNOSES (71% VS. 29%, P=0.008), MOST OF WHOM WERE OLDER (9.564.4 YEARS). IN CONTRAST, NO AE WERE OBSERVED IN 6 CHILDREN<10 KG, WHO WERE SYSTEMICALLY ANTICOAGULATED WITH HEPARIN AND REQUIRED ONLY A SINGLE PROCEDURE. THE AUTHORS FOUND THAT OLDER AND HEAVIER CHILDREN HAD THE HIGHEST AE RATES, REACHING 56% IN CHILDREN>40 KG (FIG. 1). OLDER CHILDREN WERE ALSO MORE LIKELY TO HAVE MORE PROCEDURES, INCREASING THE LIKELIHOOD FOR PROCEDURE-ASSOCIATED AE (TABLE III). "WE DID NOT OBSERVE CITRATE OR OTHER AE IN CHILDREN_10 KG, WHO WERE SYSTEMICALLY ANTICOAGULATED WITH HEPARIN. A MARKED REDUCTION IN CITRATE AE IS ALSO REPORTED USING LOW DOSE-CITRATE AND HEPARIN ANTICOAGULANT REGIMENS (10 UNITS/ML HEPARIN IN ACD-A). DISADVANTAGES OF HEPARIN ARE GREATER PROCEDURAL PLATELET LOSSES, PROLONGED COAGULATION ABNORMALITIES, BLEEDING, AND POTENTIAL HEPARIN SENSITIZATION." ARTICLE CITATION: COOLING L, HOFFMANN S, ET AL. PROCEDURE-RELATED COMPLICATIONS AND ADVERSE EVENTS ASSOCIATED WITH PEDIATRIC AUTOLOGOUS PERIPHERAL BLOOD STEM CELL COLLECTION. JOURNAL OF CLINICAL APHERESIS TRANSFUSION. 2017;32:35¿48. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
PER THE ARTICLE, 'PROCEDURE-RELATED COMPLICATIONS AND ADVERSE EVENTS ASSOCIATED WITH PEDIATRIC AUTOLOGOUS PERIPHERAL BLOOD STEM CELL COLLECTION' IN THE JOURNAL OF CLINICAL APHERESIS, A STUDY REGARDING PROCEDURE-RELATED COMPLICATIONS AND ADVERSE EVENTS (AE) ASSOCIATED WITH PEDIATRIC AUTOLOGOUS PERIPHERAL BLOOD HEMATOPOIETIC PROGENITOR (A-HPCC) CELL COLLECTION WAS DESCRIBED. IN TOTAL, 62 CHILDREN UNDERWENT 110 A-HPCC. ALL PROCEDURES WERE PERFORMED WITH COBE SPECTRA USING THE WBC COLLECTION SET. THE STUDY WAS A 4.5 YEAR RETROSPECTIVE REVIEW OF PROSPECTIVELY-COLLECTED, PROCEDURE-RELATED AE DURING HPCC AT THE (B)(6) BETWEEN 4/2009 AND 12/2013. SUMMARY: AE WERE GRADED BY SEVERITY AND TYPE. SIXTY-TWO CHILDREN UNDERWENT 110 A-HPCC, INCLUDING 36 (58%) UNDER 20 KG. FIFTY-FIVE AE WERE DOCUMENTED IN 25.4% A-HPCCS AND 39% OF CHILDREN (CITRATE 25%, ACCESS 19%, TECHNICAL 11%, CARDIOVASCULAR 0%, ALLERGIC 1.8%). NO AE WERE NOTED IN CHILDREN <10 KG ANTICOAGULATED WITH HEPARIN. ACCESS AND TECHNICAL AE ACCOUNTED FOR 73% OF SEVERE AE, WITH LINE-RELATED PROBLEMS UNDERLYING MOST TECHNICAL AE (87.5%, P=0.006). AE WERE MORE LIKELY IN OLDER (P=0.012), HEAVIER PATIENTS (P=0.02), WHO FREQUENTLY REQUIRED MORE THAN ONE A-HPCC (P=0.012). IN CONTRAST, YOUNG CHILDREN WERE MORE LIKELY TO EXPERIENCE CITRATE AE WITH GASTROINTESTINAL SYMPTOMS (MEDIAN AGE, 6 YEARS; P=0.076). AE HAD NO IMPACT ON CD34 COLLECTION RATES; HOWEVER, MEAN CD34 YIELDS (4.2 VS. 20.4 MILLION/KG; P=0.0035) WERE DECREASED IN PATIENTS WITH TECHNICAL AE DUE TO LOWER PERIPHERAL CD34 COUNTS AND A HIGH NUMBER OF ABORTED PROCEDURES (37%). CONCLUSION: VENOUS ACCESS AND FLOW-RELATED ISSUES ARE A MAJOR FACTOR ASSOCIATED WITH MODERATE AND SEVERE AE, EFFECTING ~10% OF PATIENTS. AE ARE MORE FREQUENT WITH INCREASING PATIENT AGE, WEIGHT, AND NUMBER OF PROCEDURES. (COOLING 2017). THERE WERE 14 PATIENTS WHO EXPERIENCED SIDE EFFECTS DUE TO CITRATE ANTICOAGULANT (25% OF PATIENTS, 14% [15/106] OF PROCEDURES). SPECIFIC DETAILS, INCLUDING PATIENT INFORMATION, OUTCOME, AND TYPES OF MEDICAL INTERVENTION WERE NOT PROVIDED IN THE ARTICLE, THEREFORE THIS REPORT IS BEING FILED AS A SUMMARY OF THE 14 CITRATE REACTIONS. SEVERE AE (5.4% PATIENTS) WERE LIMITED TO GASTROINTESTINAL SYMPTOMS: NO HYPOTENSION OR TETANY WERE NOTED. GASTROINTESTINAL SYMPTOMS COMPOSED THE MAJORITY OF AE (75%, 9/14) AND INCLUDED ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA. NEUROLOGIC SYMPTOMS WERE RECORDED IN 7 (12%) PATIENTS AND INCLUDED PARASTHESIAS, LIGHTHEADEDNESS, AND AGITATION. AGITATION OCCURRED IN ONE CHILD IN THREE SUCCESSIVE COLLECTIONS. COLLECTIONS WITHIN 30 MIN OF STARTING CELL COLLECTION. NEUROLOGIC SYMPTOMS, INCLUDING AGITATION, WERE MILD AND RESPONSIVE TO INCREASING THE CALCIUM REPLACEMENT INFUSION RATE. YOUNG AND SMALL CHILDREN WERE MORE LIKELY TO EXPERIENCE GASTROINTESTINAL SYMPTOMS (MEDIAN AGE 6 YEARS; MEDIAN WEIGHT 24 KG) WHEREAS NEUROLOGIC SYMPTOMS WERE MORE COMMON IN OLDER CHILDREN (MEDIAN AGE 11.8 YEARS, P= 0.076) (FIG. 2A). A REVIEW OF PRE- AND 24 H POST-PROCEDURE ELECTROLYTES SHOWED A MILDLY DECREASED TOTAL CALCIUM IN ONE PATIENT (8.0 MG/DL). INDIVIDUAL PATIENT INFORMATION AND OUTCOMES WERE NOT PROVIDED, THEREFORE, THIS REPORT IS A SUMMARY OF THE EVENT REPORTED. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459785 | COBE SPECTRA BLOOD COLLECTION | COBE SPECTRA WHITE BLOOD CELL SET, CLOSED | GKT | TERUMO BCT | 70620 | 05020583706200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |