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

[16864233] A (b)(6) year old male with a pmh of icm. , chf, hyperlipidemia, gerd, and hyperuricemia. Patient s/p heart transplant (b)(6) 2013 with post-op course, complicated by primary graft failure requiring multiple pressors and inotropes, refractory coagulopathy, respiratory insufficiency, and placement of iabp, followed by centrimag for continued rv failure. Rvad explanted (b)(6) 2013, chest closed (b)(6) 2013. Post-op course also complicated by development of renal failure requiring rrt. Patient has received intermittent hd and cvvh. , most recently changed from intermittent hd to cvvh (b)(6) starting around 1900. Patient has also developed icu myopathy, believed to be steroid-induced. Trach and peg placed (b)(6) 2013; percutaneous drain of gall bladder (b)(6) 2013 (planning to keep for 6 weeks); peg tube converted to pej (b)(6) 2013. Patient is pod #64 from heart transplantation complicated by primary graft dysfunction, refractory coagulopathy, respiratory insufficiency, steroid-induced icu myopathy, and acute renal failure requiring cvvh. For immunosuppression, tacrolimus was increased to 1. 5mg qam/1mg qpm following level of 5. 90 on 9. 3, but today decreased to 1mg bid for 10. 5. Targeting goal tacrolimus trough of 9 ng/ml. Mycophenolate mofetil dose has been reduced to 500 mg iv q12hr due to recent leucopenia and invasive aspergillosis. Steroid dose has been tapered rapidly over hospital course due to neurology's concern for possible steroid-induced myopathy. Dose has been reduced based on negative biopsies; patient is currently receiving methylprednisolone 10mg iv daily with no plan to further reduce the dose at this time. Neurologically, low dose seroquel at bedtime. Cardiovascularly, has not been able to wean pressors - on norepi and vasopressin; still receiving midodrine for blood pressure support while in cvvh. Pulmonary function has improved over hospital course; currently on trach collar with 40% fio2. Gi ppx with esomeprazole; currently receiving tf at goal 50ml/hr. Patient has acute renal failure, requiring intermittent hd and cvvh during hospitalization; recently changed from intermittent hd back cvvh, starting (b)(6) 1900. Not making any urine. We're watching electrolytes and had to replete phos today. Heme: patient is receiving dvt prophylaxis with subcutaneous heparin. Id: patient has consistently grown pseudomonas from respiratory cultures since (b)(6) 2013. As of (b)(6), growing 2 strains of pseudomonas (1 strain susceptible only to aminoglycosides, 2nd strain suspectable to aminoglycosides, cefepime, and aztreonam). Culture (b)(6) grew only 1 strain susceptible to aminoglycosides, cefepime, and aztreonam. Per transplant id, treating pseudomonas with gentamicin; dosing has been based off of levels as patient was on cvvh, then switched to intermittent hd, then back to cvvh as of 8/27(b)(6). Based on most recent gent levels, dose was adjusted down to 300mlg q48gh. Biopsy of lung nodule and fungal culture are positive for aspergillosis, being treated per transplant id with voriconazole 350mg iv q12h. Voriconazole trough level (b)(6) was low (0. 5 mcg/ml); trough level (b)(6) was 1. 1 mcg/ml (goal trough 1-4 mcg/ml). Merrem and zyvox (originally for concern of nocardia) have been discontinued as id does not feel this is warranted. Cefepime was started instead to double cover pseudomonas. Receiving smx/tmp for pcp prophylaxis and valganciclovir 450 mg mwf for cmv prophylaxis. His cardiac function appeared to resolve with evidence of preserved heart function. He underwent several biopsies, which showed grade 0r rejection. There was no evidence of rejection. While on immunosuppression, he developed aspergillus pneumonia, which was treated by voriconazole. Initially, he had clinical improvement. He subsequently developed pseudomonas pneumonia, which was resistant to meropenem. Unfortunately, he developed clinical decompensation with development of pseudomonas pneumonia. He required the need of pressors, levophed, vasopressin, and dopamine. Despite treatment, he ultimately passed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037014
MDR Report Key3913126
Date Received2014-06-27
Date of Report2014-06-26
Date of Event2013-07-03
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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