MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-08-25 for INTERCEPT BLOOD SYSTEM FOR PLASMA manufactured by Cerus Corporation.
[83731452]
Cerus medical assessment: cerus medical reviewer concurs with the reporter's assessment that the event of "anaphylactic shock" was severe and serious due to being life-threatening and likely to be related to the transfusion of intercept treated plasma component. Severe allergic reactions, such as anaphylactic shock, are rare, with an estimated incidence of 1/20. 000 to 47. 000 units of blood components. Event is not unexpected. Allergic reactions typically present as rash, urticaria, or pruritus and are indistinguishable on examination from most food or drug allergies. Allergic reactions are ige mediated. These reactions are usually attributed to hypersensitivity to allogeneic proteins in plasma, on leukocytes or platelets or, uncommonly, soluble allergens found in the transfused blood component. Anaphylactic reactions have been reported to be associated with anti-iga in recipients who are iga deficient. However, while anaphylactic reactions do occur, uncommonly, the link to anti-iga is not regarded as evidence based. No device malfunction was reported. Domen r. E. , hoeltge g. A. Allergic transfusion reactions. Arch pathol lab med. Vol 127, march 2003 [medline]. Sandler sg, mallory d, malamut d, eckrich r. Iga anaphylactic transfusion reactions. Transfus med rev. 1995 jan. 9 (1):1-8. [medline]. Sandler sg, eder af, goldman m, winters jl. The entity of immunoglobulin a-related anaphylactic transfusion reactions is not evidence based. Transfusion. 2015 jan. 55 (1):199-204. [medline].
Patient Sequence No: 1, Text Type: N, H10
[83731453]
Date reported: (b)(6) 2017 (in) (b)(6) female patient. Case (b)(4) is a spontaneous report received on 27-jul-2017 from a member of the directive board of the (b)(6) in (b)(6). Further information on the initial report was received on 04-aug-2017, 07-aug-2017, 10-aug-2017, 14-aug-2017, 17-aug-2017 and 18-aug-2017. This report involves a (b)(6), caucasian female who received intercept treated plasma components and experienced a serious adverse event of anaphylactic transfusion reaction [pt: anaphylactic transfusion reaction]. The patient's primary diagnosis is wegener's granulomatosis with alveolar hemorrhage. The patient's concomitant medications included metilprednisolone and cyclophosphamide. The patient's medical history was not reported. The patient did not have a history of transfusion reaction. On (b)(6) 2017, intercept plasma was made out of a pool of 5 whole blood derived units to produce 6 units for transfusion. It was reported that all the blood donors are regular donors with no past history of recipient transfusion reactions to their donated blood components. The original plasma pool (lot: 1740291), was split into two intermediate pools, 1740292 and 1740293. Both intermediate pools were subject to intercept treatment (product id: int3104; lot: ce16d05l61). Following intercept treatment, 6 ifp units were created: (b)(6). The second intercept plasma unit, (b)(6), was implicated in the serious adverse event of anaphylactic transfusion reaction. On (b)(6) 2017 at 22:09h, the units from the intermediate pool ((b)(6)) were released from the blood bank to the hospital. On (b)(6) 2017, the patient was admitted to the hospital for an unspecified reason. On (b)(6) 2017, the patient was transferred to the icu (intensive care unit) for wegener's granulomatosis with alveolar hemorrhage. The patient was scheduled to undergo therapeutic plasma exchange sessions (tpe) with intercept treated plasma units. The reporter noted that the patient had not received intercept treated plasma before. On the same day, the patient completed her 1st session of tpe with no reported transfusion reactions. The patient received a total of 8 units of intercept treated plasma, including a unit collected from the first intermediate plasma pool ((b)(6)). On (b)(6) 2017, the patient initiated her 2nd tpe session and received 4 plasma units ((b)(6)). At 16:20h, after transfusing 50 ml of the fourth plasma unit ((b)(6)), the patient experienced a serious adverse event of anaphylactic transfusion reaction. The patient experienced urticaria, hypotension, shock and increased respiratory work. The patient's vitals prior to transfusion were as follows: blood pressure (bp) was 140/73 mmhg, body temperature was 37. 7 degrees celsius and heartrate was 70 beats per minute (bpm). The patient's vitals during the time of transfusion reaction were as follows: bp was 55/36 mmhg, body temperature was 37. 3 degrees celsius and heart rate was 100 bpm. The transfusion was immediately stopped and discontinued due to the reaction. The patient was treated with 1. 5mg of adrenaline, 20mcg/min of noradrenaline, clemastin (clemastine fumarate) and hydrocortisone. At 16:50h, approximately 30 minutes after the start of transfusion, the patient was reported to have stabilized following treatment. At unspecified dates, the patient's remaining tpe sessions were substituted with sd plasma (octaplas). Two units from the same pool, (b)(6), were confirmed to be transfused to other patients with no reported transfusion reactions. The remaining unused units from the same pool, (b)(6), were recalled by the blood bank. On (b)(6) 2017, the patient completed her last session of tpe. On (b)(6) 2017, the patient was transferred to the medicine ward from icu, and currently being followed by the physiatry unit. On (b)(6) 2017, the reporter confirmed that investigations are being conducted to trace back to the other intercept plasma units belonging to the same pool to determine the outcome of the transfusions. Clinical outcome will be collected for the units that have been transfused. The reporter added that all the units were released in (b)(6) with no complaints until the report involving intercept plasma unit (b)(6) was identified. The reporter confirmed that the serious adverse reaction of "anaphylactic transfusion reaction" was reported to the portuguese hemovigilance system on (b)(6) 2017. On (b)(6) 2017, the pathogen inactivation treatment report was provided for lot 1740293 which showed successful illumination with no indication of malfunction or irregularities. On (b)(6) 2017, the reporter indicated that there is a possibility to retrieve a blood sample from the patient to check for antibodies for amotosalen. Arrangements are in progress to collect the patient's plasma samples and provide to cerus. Reporter assessment: the treating physician assessed the event of "anaphylactic transfusion reaction" as grade 3 (severe) in severity and the serious due to the event being life-threatening. The treating physician considered the causality for the event to be probable in relation to transfused intercept treated plasma. The treating physician considered the causality for the event to be possible in relation to the intercept blood system. Cerus medical assessment: cerus medical reviewer concurs with the reporter's assessment that the event of "anaphylactic shock" was severe and serious due to being life-threatening and likely to be related to the transfusion of intercept treated plasma component. Severe allergic reactions, such as anaphylactic shock, are rare, with an estimated incidence of 1/20. 000 to 47. 000 units of blood components. Event is not unexpected. Allergic reactions typically present as rash, urticaria, or pruritus and are indistinguishable on examination from most food or drug allergies. Allergic reactions are ige mediated. These reactions are usually attributed to hypersensitivity to allogeneic proteins in plasma, on leukocytes or platelets or, uncommonly, soluble allergens found in the transfused blood component. Anaphylactic reactions have been reported to be associated with anti-iga in recipients who are iga deficient. However, while anaphylactic reactions do occur, uncommonly, the link to anti-iga is not regarded as evidence based. No device malfunction was reported. Domen r. E. , hoeltge g. A. Allergic transfusion reactions. Arch pathol lab med. Vol 127, march 2003 [medline]. Sandler sg, mallory d, malamut d, eckrich r. Iga anaphylactic transfusion reactions. Transfus med rev. 1995 jan. 9 (1):1-8. [medline]. Sandler sg, eder af, goldman m, winters jl. The entity of immunoglobulin a-related anaphylactic transfusion reactions is not evidence based. Transfusion. 2015 jan. 55 (1):199-204. [medline].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2017-00002 |
| MDR Report Key | 6822972 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-25 |
| Date of Report | 2017-07-27 |
| Date of Event | 2017-06-02 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROL MOORE |
| Manufacturer Street | 2550 STANWELL DRIVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLASMA |
| Generic Name | INTERCEPT BLOOD SYSTEM FOR PLASMA |
| Product Code | PJF |
| Date Received | 2017-08-25 |
| Lot Number | CE16D05L61 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERUS CORPORATION |
| Manufacturer Address | CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-08-25 |