MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-29 for INTERCEPT BLOOD SYSTEM FOR PLATELETS INT2110 manufactured by Cerus Corporation.
[118805783]
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 assessed the (b)(6) 2018 event of allergic transfusion reaction [pt: allergic transfusion reaction] as grade 3 in severity and serious because it was medically significant. The investigator considered the causality for the event to be likely/probable in relation to intercept blood system for platelets with a suspected allergy to psoralen or to amotosalen. The investigator assessed the (b)(6) 2018 event of allergic transfusion reaction [pt: allergic transfusion reaction] as grade 3 in severity and serious because it was medically significant. The investigator considered the causality for the event to be likely/probable in relation to intercept blood system for platelets with a suspected allergy to psoralen or to amotosalen. On 03-aug-2018: cerus medical assessment: cerus medical reviewer agrees with the reporter's assessment that the (b)(6) 2018 event of allergic transfusion reaction [pt: allergic transfusion reaction] was grade 3 in severity and serious because it was medically significant as there were clinical indications of an anaphylactic reaction (chest tightness). The cerus medical reviewer agrees that the causality for the event of allergic transfusion reaction [pt: allergic transfusion reaction] was likely/probable in relation to the platelet transfusion due to the temporal relationship. An allergic transfusion reaction is an expected event with any blood component. The medical reviewer considers the relationship to the intercept blood system of platelets as possibly related, pending further investigation. Specifically, further medical history is required to understand the patients' history of allergic reactions to conventional platelets, given the routine use of hydrocortisone premedication prior to the first reaction to intercept platelets. Investigation of antibodies to amotosalen or intercept treated platelets would also be required to implicate the intercept process definitively. Cerus medical reviewer agrees with the reporter's assessment that the (b)(6) 2018 event of allergic transfusion reaction [pt: allergic transfusion reaction] was grade 3 in severity and was likely/probable in relation to the platelet transfusion due to the temporal relationship. The clinical description does not indicate a serious reaction as the description is in keeping with a mild allergic reaction with no evidence of systemic effects (e. G. , hypotension, bronchospasm etc. ). An allergic transfusion reaction is an expected event with any blood component. The medical reviewer considers the relationship to the intercept blood system of platelets as possibly related, pending further investigation. Specifically, further medical history is required to understand the patients' history of allergic reactions to conventional platelets, given the routine use of hydrocortisone premedication prior to the first reaction to intercept platelets. Investigation of antibodies to amotosalen or intercept-treated platelets would also be required to implicate the intercept process definitively. Cerus will conduct further investigations to elucidate these events.
Patient Sequence No: 1, Text Type: N, H10
[118805784]
Allergic transfusion reaction [allergic transfusion reaction]. Case description: date cerus received: 24-jul-2018, 27-jul-2018, 30-jul-2018,31-jul-2018, 02-aug-2018, 22-aug-2018 (in). The patient involved in this report is (b)(6)-year-old female. Continued in additional info section....
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2018-00005 |
| MDR Report Key | 7830768 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-29 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-06-24 |
| Date Mfgr Received | 2019-01-28 |
| Date Added to Maude | 2018-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CAROL MOORE |
| Manufacturer Street | 2550 STANWELL DRIVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9258766819 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Generic Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Product Code | PJF |
| Date Received | 2018-08-29 |
| Model Number | INT2110 |
| Lot Number | CE18A04L61 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERUS CORPORATION |
| Manufacturer Address | 2550 STANWELL DRIVE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |