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Patient 1
ON 24-JUL-2018, CERUS RECEIVED A SERIOUS SPONTANEOUS REPORT [(B)(4)] FROM THE DIRECTOR OF THE TRANSFUSION SERVICE AT (B)(6) MEDICAL CENTER, UNITED STATES. FURTHER INFORMATION ON THE INITIAL REPORT WAS RECEIVED BETWEEN 25-JUL-2018 TO 02-AUG-2018. THE REPORT INVOLVES (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED INTERCEPT TREATED PLATELET COMPONENTS (PC) FOR THROMBOCYTOPENIA, AND WHO EXPERIENCED TWO SEPARATE SERIOUS ADVERSE EVENTS OF ALLERGIC TRANSFUSION REACTION [PT: ALLERGIC TRANSFUSION REACTION]. THE PATIENT'S PRIMARY DIAGNOSIS IS CHRONIC MYELOMONOCYTIC LEUKEMIA. THE PATIENT'S CONCURRENT CONDITION IS THROMBOCYTOPENIA. CONCOMITANT MEDICATIONS INCLUDED ALLOPURINOL [ALLOPURINOL], ONDANSETRON [ONDANSETRON], PROCHLORPERAZINE [PROCHLORPERAZINE], MULTIVITAMIN [ASCORBIC ACID, CALCIUM PANTOTHENATE, ERGOCALCIFEROL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE], PYRIDOXINE [PYRIDOXINE], ELTROMBOPAG [ELTROMBOPAG], DIPHENHYDRAMINE [DIPHENHYDRAMINE], HYDROCORTISONE [HYDROCORTISONE], ACETAMINOPHEN [PARACETAMOL], DOCUSATE SODIUM [DOCUSATE SODIUM]. ACCORDING TO A REPORT SUBMITTED BY THE DIRECTOR OF THE (B)(6) MEDICAL CENTER TRANSFUSION SERVICE, THE PATIENT RECEIVED 12 PLATELET COMPONENTS OVER A 1-2 MONTH PERIOD (DATES NOT SPECIFIED). THE PATIENT WAS REPORTED TO HAVE RECEIVED A MIXTURE OF BOTH CONVENTIONAL AND INTERCEPT PCS. THREE OF THE 12 PLATELET COMPONENTS WERE TREATED WITH THE INTERCEPT BLOOD SYSTEM FOR PLATELETS. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY REACTIONS ASSOCIATED WITH THE TRANSFUSION OF THE 9 CONVENTIONAL PLATELETS, OR WITH THE FIRST OF THE 3 INTERCEPT-TREATED PLATELET COMPONENTS. THE PATIENT WAS TRANSFUSED ON THE FOLLOWING DATES: (B)(6) 2018, THE PATIENT RECEIVED INTERCEPT PCS. (B)(6) 2018 AT 15:15H-15:45H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 14:15H-14:55H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 10:45H -11:20H, THE PATIENT RECEIVED INTERCEPT PCS. (B)(6) 2018 AT 16:02H-17:25H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT16:15H -16:35H, THE PATIENT RECEIVED INTERCEPT PCS. (B)(6) 2018 AT16:15H -16:35H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 13:45H-14:00H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 15:20H-16:00H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 10:45H-11:00H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 12:50H-13:55H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. (B)(6) 2018 AT 15:15H-15:55H, THE PATIENT RECEIVED CONVENTIONAL PLATELETS. ON (B)(6) 2018, THE PATIENT RECEIVED AN INTERCEPT PC COMPONENT (TRANSFUSION #1) WITHOUT INCIDENT. ON (B)(6) 2018 10:45H, THE PATIENT RECEIVED AN INTERCEPT PC COMPONENT (TRANSFUSION #2) AND EXPERIENCED A SERIOUS EVENT OF ALLERGIC TRANSFUSION REACTION [PT: ALLERGIC TRANSFUSION REACTION]. THE PATIENT WAS SEEN AS AN OUTPATIENT IN THE CANCER CENTER FOR CHRONIC MYELOMONOCYTIC LEUKEMIA AND SEVERE THROMBOCYTOPENIA WITH EPISTAXIS. PRIOR TO THE TRANSFUSION, THE PATIENT WAS PRE-MEDICATED WITH HYDROCORTISONE 100 MG INTRAVENOUSLY, ACETAMINOPHEN 650 MG ORALLY, AND DIPHENHYDRAMINE 25 MG ORALLY. THE PATIENT'S PLATELET COUNT PRIOR TO THE TRANSFUSION WAS 21K/MCL. AT 11:20H, APPROXIMATELY 35 MINUTES INTO THE INTERCEPT PC TRANSFUSION, THE PATIENT DEVELOPED ITCHING AND REDNESS OF THE PALMS WITH CHEST TIGHTNESS. THE TRANSFUSION WAS DISCONTINUED AS A RESULT OF THESE SYMPTOMS. THE PATIENT WAS TREATED WITH FAMOTIDINE 20MG INTRAVENOUSLY AND HER SYMPTOMS RESOLVED. THE PATIENT'S VITALS DURING THE TRANSFUSION REACTION WERE AS FOLLOWS: BODY TEMPERATURE: 98.6 F, BLOOD PRESSURE: 139/64 MMHG, PULSE: 80 BPM. THE OUTCOME FOR THE EVENT OF ALLERGIC TRANSFUSION REACTION [PT: ALLERGIC TRANSFUSION REACTION] WAS REPORTED AS RECOVERED. ON (B)(6) 2018 16:15H, THE PATIENT RECEIVED A 133ML INTERCEPT PC COMPONENT (TRANSFUSION #3) AND EXPERIENCED ANOTHER SERIOUS EVENT OF ALLERGIC TRANSFUSION REACTION [PT: ALLERGIC TRANSFUSION REACTION]. THE PATIENT HAD BEEN PRE-MEDICATED WITH H1 AND H2 BLOCKERS AND A CORTICOSTEROID BASED ON THE PREVIOUS REACTION WITH INTERCEPT PCS. THE PATIENT'S PLATELET COUNT PRIOR TO TRANSFUSION WAS 10 K/MCL. THE PATIENT'S VITALS PRE-TRANSFUSION WERE AS FOLLOWS: BODY TEMPERATURE: 98 F, BLOOD PRESSURE: 125/56 MMHG, PULSE: 79 BPM. AT 16:35H, APPROXIMATELY 20 MINUTES INTO THE INTERCEPT PC TRANSFUSION, THE PATIENT EXPERIENCED FLUSHING WITH HIVES AND ITCHING. THE TRANSFUSION WAS DISCONTINUED AS A RESULT OF THESE SYMPTOMS. THE PATIENT WAS TREATED WITH DIPHENHYDRAMINE AND HYDROCORTISONE AND THE SYMPTOMS RESOLVED. THE PATIENT'S VITALS DURING THE TRANSFUSION REACTION WERE AS FOLLOWS: BODY TEMPERATURE: 98.5 F, BLOOD PRESSURE: 123/58 MMHG, PULSE: 85 BPM. THE OUTCOME FOR THE EVENT OF ALLERGIC TRANSFUSION REACTION [PT: ALLERGIC TRANSFUSION REACTION] WAS REPORTED AS RECOVERED; HOWEVER, IT WAS NOTED THAT THE PATIENT WAS VERY UNCOMFORTABLE WITH RECEIVING ADDITIONAL PLATELETS AFTER THIS REACTION. REPORTER ASSESSMENT: THE INVESTIGATOR...