MAUDE Adverse Event Report:; NONE

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Pleural Effusion (2010); Respiratory Distress (2045); Septic Shock (2068); Ventricular Tachycardia (2132); Respiratory Failure (2484); Multiple Organ Failure (3261); Pericardial Effusion (3271)

Event Date 04/08/2015

Event Type  No Answer Provided  

Event Description

This report concerns (b)(6) year-old (b)(6) male who was treated under a (b)(6), an expanded access study using the clinimacs system to offer therapeutic manipulated grafts that are cd34 cell enriched and t cell depleted for allogeneic stel cell recipients with mismatched related donors or borderline organ function".On (b)(6) 2015, the subject was admitted to the hospital for urosepis (serratia, enterococcus and gpc bacteremia), persistent epistaxis, and oxygen requirement.It was noted at the time of admission that the patient's nephrostomy tubes we growing serratia and citrobacer.The nephrostomy tubes were removed and the patient was treated for urosepsis.During this admission, the patient developed pvcs with intermittent bigeminy and trigeminy.On (b)(6) 2015, he developed svt which was corrected with one dose of adenosine.He was placed on atenolol for prevention of further svt.On (b)(6) 2015, the patient was transferred to the picu for chest discomfort in the context of dysrhythmia with bigeminy and perfusion of 50 percent of traced beats.His pulse was noted to be in the 80's with perfusion noted in the 40s.During his picu stay, the patient severe chest pain in the setting of right lower lobe consolidation, pleural effusion and pericardial effusion.On (b)(6) 2015, he started having hypotension requiring fluid bolus and the initiation of epinephrine infusion.His respiratory distress progressed to respiratory failure requiring endotracheal intubation and mechanical ventilation.Patient was subsequently started on broad spectrum antimicrobials (vancomycin, meropenem, liposomal amphotericin b).He was also started on stress dose steroids in the context of septic shock.The respiratory failure was progressive and respiratory support was escalated initially on volume control with low tidal volume with high peep (positive end expiratory pressure).Persistent hypoxemia pressure control mode was initiated and eventually the patient was started on aprv (airway pressure release ventilation).The patient's hypotension was progressive requiring escalation of epinephrine infusion, intermittent boluses of calcium chloride, vasopressin infusion, multiple boluses of sodium biocarbonate, and tham to buffer metabolic acidosis in the setting of shock and high doses of catcholamines requirement.He subsequently developed end organ function failure (liver and renal).The patient went into pea (pulseless electrical activity) arrest and cpr was initiated.Cpr continued for a total of 10 minutes.Return of spontaneous circulation was noted.Given the multi organ failure, septic shock, persistent hypoxemia, and refractory lactic acidiosis, with an overall poor prognosis, the patient's family requested withdrawal of support.Patient died on (b)(6) 2015 at 1105 am.Other remarks: we do not believe that the patient's cause of death was related to the use of the test article.

• Type of Device: NONE
• MDR Report Key: 4706636
• MDR Text Key: 5724130
• Report Number: 4706636
• Device Sequence Number: 1
• Product Code: OVG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2015,04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Distributor Facility Aware Date: 04/08/2015
• Event Location: Hospital
• Patient Sequence Number: 1
• Treatment: EPOETIN ALFA ((B)(6) 2015); DIPENHYDRAMINE ((B)(6) 2015); IVIG ((B)(6) 2015); DOPAMINE ((B)(6) 2015); CYCLOSPORIN ((B)(6) 2015); FILGRAMSIN ((B)(6) 2015); ETOMIDATE ((B)(6) 2015); CIDOFOVIR ((B)(6) 2015); LORAZEPAM ((B)(6) 2015); MEROPENEM ((B)(6) 2015); CALCITROL ((B)(6) 2015); AMPHOTERICIN B LIPOSOMAL ((B)(6) 2015); EPINEPHRINE ((B)(6) 2015); METHYLPREDNISOLONE ((B)(6) 2015); VANCOMYCIN ((B)(6) 2015)
• Patient Outcome(s): Death
• Patient Age: 18 YR
• Patient Weight: 52