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 .

Event Text Entries

[4664955] (b)(4) mr. (b)(6) has ho/o eosinophilic myocarditis and advanced congestive heart failure recently started on home dobutamine and his status was upgraded to 1b. Since starting home dobutamine he feels much better and is able to walk 20-30 minutes daily, though the grocery story, cook, and walk single flights of stairs without fatigue and legs "giving out". No orthopnea, pnd, chest discomfort, or palpitations. Last week he reported a 9 pound weight gain and took additional dose of zaroxolyn with 5 pound weight loss overnight. Dobutamine is stable at 5 mcg/kg/min. Past medical history: eosinophilic myocarditis, cva,/chf with right heart failure, thrombocytopenia, clostridium difficile colitis, left ventricular apical thrombus, chronic renal insufficiency donor available and patient underwent heart transplant on (b)(6) 2013 which was complicated by primary graft failure requiring multiple inotropes/pressors, placement of iabp, and av ecmo. Patient was taking warfarin at home; however, case was not complicated by refractory coagulopathy (patient received pcc 2000 units iv) (b)(6) 2013 av ecmo (b)(6) 2013: decannulated from av ecmo (b)(6) 2013: discontinued iabp (b)(6): patient extubated (b)(6): rhc/biopsy, echo (b)(6): rhc/biopsy (b)(6): echo (b)(6): biopsy (b)(6): transfer to floor. Pod #91 from heart transplant complicated by primary graft non-function and now ready for discharge today to acute rehab facility. Neurologically on tramadol prn for pain control. Patient's mental status continues to be totally clear. Patient continues significant weakness due to deconditioning, continues with aggressive pt/ot. Also with significant depression/adjustment disorder being followed by psychiatry who also recommended initiation and upward titration of celexa and ativan prn. Cardiovascular continues with allograft dysfunction with low ef. Last rhc continued to demonstrate elevated filling pressures with emb showing no evidence of rejection. Medications at this time include pravastatin, spironolactone and bymex. Patient intolerant to acei and b-blocker therapy in the past secondary to hypotension and declining renal function. Plan to continue with diuresis as tolerated for bp and renal function. Will be scheduled for repeat emb next week as outpatient. Repeat echo continues to show evidence of mass in lv apex. Plan to get contrasted echo prior to discharge today to fully assess. Will start aspirin 325 mg po daily on discharge. No plans for further anticoagulation at this time secondary to increased risk of bleeding and biopsy schedule. Id, no active issues at this time. Clotrimazole started on (b)(6) for fungal prophylaxis since patient can now take po tablets. Since immunosuppression was induced with thymoglobulin, cmv prophylaxis continues now with oral valcyte at 450mg po q mon and (b)(6) based on present renal function. Platelet count continues to be normal at this time. Have no initiated septra ss for pcp prophylaxis. Heparin 5000 units sc q8hrs initiated for dvt prophylaxis. Will continue to observe platelet count closely for recovery. Will continue to follow eosinophil county weekly and consider restarting gleevec per heme recs for preop diagnosis of eosinophilic myocarditis if absolute eosinophil count is more than 1000. On (b)(6) 2014, the patient became hypoxic. At that time, he was intubated and further evaluation was pursued with a ct of the chest with contrast. Ct of the chest with contrast revealed multiple bilateral subsegmental pulmonary emboli. He was started on heparin. Apparently, he was treated for cryptococcus atypical pneumonia. Fungal and hospital-acquired pathogens with vancomycin, meropenem, levaquin, tobramycin, and voriconazole. Given the clinical picture with no improvement despite broad antibiotic coverage for infection, inotropes, cvvh, ventilatory support for respiratory failure, he continues to decline. He died on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037016
MDR Report Key3913149
Date Received2014-06-27
Date of Report2014-06-26
Date of Event2013-08-27
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 NumberCIE-354-02
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization; 3. Required No Informationntervention 2014-06-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.