MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-07-29 for INTERCEPT BLOOD SYSTEM FOR PLATELETS manufactured by Cerus Corporation.
[21768650]
It was reported that on (b)(6) 2014 a (b)(6) , male pt was transfused with one unit of intercept platelets (platelet count before transfusion 79,000 x 109/l) in preparation for a scheduled lumbar decompression surgery (l4/l5). Upon arrival to the operating room, the pt suffered from an anaphylactic reaction characterized by generalized pruritus, generalized erythema, malaise, urticaria, hypotension (111/65 mmhg), shock, and hypoxemia (oxygen saturation less than 90%). The pt received treatment with methylprednisolone iv. Surgery was cancelled and an arterial line was inserted to record blood pressure continuously and oxygen therapy was administered through nasal cannula. Despite these measures, the pt's blood pressure dropped to 85/60 mmhg. The pt received intravenous fluids and two boluses of adrenaline (0. 1 mg iv). Due to his unstable circulatory situation, the pt was admitted to the intensive care unit where he received l-adrenaline (1 mg/50 ml at 20ml/h) via an infusion pump. The pt was breathing spontaneously; there was no sign of bronchospasm. Chest-x-rays revealed discrete bilateral basal congestion of lung parenchyma. Chemistry and clinic did not show symptoms/signs of inflammation. Intermittent cpap ventilation was delivered over 2 days and the pt was mobilized. Pt fully recovered from the event and was admitted to internal medicine ward on (b)(6) 2014. In total he received 3,500 ml crystalloids, 2 ampules of ranitidine and methylprednisolone (250 mg iv). Blood specimens were taken for an antiplatelet antibody test and sent to the immunological platelet diagnostics unit at the (b)(6) hospital. No report was available at the time of this report. The pt never returned to the hospital for follow-up. Reporter assessment: an anaphylactic reaction event following transfusion of intercept platelet components. The treating physician considered the event to be possibly related to the transfusion of platelets. Cerus medical assessment: the cerus medical reviewer concurs with the reporter's assessment. Allergic reactions to platelet transfusion due to ige directed against proteins in the donor plasma are relatively common. Anaphylactic reactions, albeit rare, have been known to occur following the transfusion of platelet components. These are associated with rapid onset of shock, angioedema, and respiratory distress. Many cases occur due to the production of anti iga antibodies in recipients who are iga deficient. Severe anaphylactic reactions have a reported incidence of 1:20,000 to 50,000 but are believed to be more common. Latex, drugs, foods in donors can lead to severe reactions in susceptible recipients.
Patient Sequence No: 1, Text Type: D, B5
[22077617]
This is a foreign event that occurred in (b)(6) on (b)(6) 2014 prior to cerus' intercept blood system for platelets pma (b)(4) approval. Cerus became aware of this event on (b)(6) 2015 and cerus has made the effort to obtain additional info; however, no follow-up info is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003925919-2015-00001 |
| MDR Report Key | 4955807 |
| Report Source | 01,05 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-07-01 |
| Date of Event | 2014-07-16 |
| Date Mfgr Received | 2015-07-01 |
| Date Added to Maude | 2015-08-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2550 STANWELL DR |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9252886000 |
| 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 | 2015-07-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERUS CORPORATION |
| Manufacturer Address | 2550 STANWELL DR CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-29 |