CELSIOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-27 for CELSIOR manufactured by Sanofi-aventis.

Event Text Entries

[4584940] A (b)(6) male s/p mi, s/p cabg in 1995 developed ischemic cardiomyopathy with systolic heart failure requiring milrinone and listed 1b for cardiac transplantation. He was subsequently transplanted on (b)(6) 2013. Other factors pretransplant included previous sternotomy for cabg and coumadin therapy. Transplant complicated by intra-operative acute right heart failure requiring placement of rvad, refractory coagulopathy requiring administration of multiple blood products. Profilnine, and factor vii, and post-opt acute respiratory failure requiring emergent placement of oxygenator into rvad circuit for further mechanical ventilatory support and subsequently biventricular failure requiring conversion to v/a ecmo. Patient is cmv+, donor cmv-. Pod7 from heart transplant complicated by intra-operative acute right heart failure requiring placement of rvad, refractory coagulopathy requiring administration of multiple blood products, profilnine, and factor vii, and post-opt acute respiratory failure requiring emergent placement of oxygenator into rvad circuit for further mechanical ventilatory support and subsequent biventricular failure requiring conversion to v/a ecmo. Taken to operating room this 5/7 for mediastinal exploration/washout, movement of ecmo ra venous cannula to l femoral vein, and partial wound closure with placement of wound vac. Central line changeout on (b)(6) 2013. Will continue sedation with propofol and analgesia with morphine drip at this time. Will continue to cardiopulmonary support with v/a ecmo and attempt to wean norepinephrine, vasopressin, and neosynephrine as tolerated to support map. Continues with acute lung injury secondary most likely to massive transfusion requirements. Will support with v/a ecmo and attempt to remove volume with cvvhd when able to aid with lung recovery. Presently receiving iv nexium for gi prophylaxis. Tube feeds held again this am for line changes. Patient continues on cvvhd for crrt. Little uop at this time and potassium marginally controlled. Will continue to follow closely and adjust medications accordingly to account for removal with cvvhd. Antimicrobials include vancomycin, zosyn and fluconazole for pre-emptive therapy for open chest in highly immunosuppressed patient with mechanical circulatory support device, and ganciclovir for cmv prophylaxis with use of induction therapy with thymoglobulin. Will consider pcp prophylaxis with bactrim at a later time. Will continue with insulin drip for glycemic control and synthroid at 50 mc/iv daily (1/2 home po dose) for pre-opt hx of hypothyroidism. Will consider initiation of statin therapy in the future. Patient with evidence of thrombus in oxygenator and fibrin streaking in the ecmo cannula's. Heparin drip initiated on 5/4 and held 5/5 for re-exploration and washout x 2. Re-initiated at lower dose in evening of 5/5 with planned titration for aptt of 80-90 seconds. Heparin drip discontinued in am on 5/7 for op procedure but subsequently restarted at 6 units/kg/hr on 5/7. Continuing to titrate to goal axa of ~0. 4 units per ml or aptt of ~ 80 seconds for now. Will need to follow hemostasis issues and observe ecmo circuit very closely. Cd3 count today 9 cells/ul. Will continue to monitor cd3 counts and redose thymoglobulin for cd3 counts greater than 25 cells/ul for induction and withhold calcineurin inhibitors at this time with compromised renal function. Will continue cellcept at present doses and follow hematologic indices closely to consider reduction in cellcept dose if required. Will decrease methylprednisolone to 30mg iv q12hrs (0. 73 mg/kg/day). A transesophageal echocardiogram was performed on postoperative day 8 which did not demonstrate any cardiac activity. Thus, he was continued on extracorporeal membrane oxygenation. On the morning of postoperative day 11, his nurses evaluated him and noticed that he had a fixed and dilated pupil on the left and had lost corneal reflex on that side. He also no longer had a gag reflex. Pt expired on pod 11.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037015
MDR Report Key3913146
Date Received2014-06-27
Date of Report2014-06-26
Date of Event2013-05-02
Date Added to Maude2014-07-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCELSIOR
Generic NameCELSIOR-DONOR HEART PRESERVATION, IL
Product CodeMSB
Date Received2014-06-27
Lot NumberCE-307-01
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerSANOFI-AVENTIS


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization 2014-06-27

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