MAUDE Adverse Event Report: CERUS CORPORATION INTERCEPT BLOOD SYSTEM FOR PLATELETS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Shock (2072); Anaphylactoid (2218); Malaise (2359)

Event Date 07/16/2014

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: INTERCEPT BLOOD SYSTEM FOR PLATELETS
• Type of Device: INTERCEPT BLOOD SYSTEM FOR PLATELETS
• Manufacturer (Section D): CERUS CORPORATION; 2550 stanwell dr; concord CA 94520
• Manufacturer Contact: 2550 stanwell dr; concord, CA 94520 ; 9252886000
• MDR Report Key: 4955807
• MDR Text Key: 21768650
• Report Number: 3003925919-2015-00001
• Device Sequence Number: 1
• Product Code: PJF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: BP140143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PANTOPRAZOLE; CHLORIDE; ROSUVASTATIN; RILMENIDINE; GLICAZIDE; GABAPENTIN; INSULIN; VALSARTAN; POTASSIUM; SITAGLIPTIN/METFORMIN
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR