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

[4489455] A (b)(6) year old male with hx of viral myocarditis (parvovirus b 19) with resulting cardiomyopathy s/p heartmate ii lvad placement as bridge to transplant and subsequently transplanted on (b)(6) 2013 with heartmate ii lvad explantation. Transplant complicated by primary nonfunction of the graft requiring placement of bivad support and refractory coagulopathy with open chest requiring administration of multiple blood products, profilnine, and factor vii. Of note, pt is high risk for cmv because position donor, negative recipient. Chest closed on (b)(6) 2013. Operating room on (b)(6) 2013 for lvad removal. Operating room on (b)(6) 2013 for rvad removal. Extubated on (b)(6) 2013. Cvvhd discontinued on (b)(6) 2013. Hd initiated on (b)(6) 2013. Transferred to floor on (b)(6) 2013. Pod # 30 after heart transplantation complicated by primary graft nonfunction requiring bivads; refractory coagulopathy requiring open chest and multiple blood transfusions (over 120 units of blood products), profilnine, and factor vii; hypoxia with increasing fio2 requirements; and hypocalcemia. Chest able to be closed on (b)(6) 2013. Lvad was able to be removed on (b)(6) 2013. Rvad removed in operating room on (b)(6) 2013. Pt was successfully extubated on (b)(6) 2013 and subsequently discontinued from cvvhd on (b)(6) 2013, begun on hd on (b)(6) 2013, and transferred to the floor on (b)(6) 2013. Cardiac wise continues to improve in graft function/recovery with lvad support weaned and subsequently removed on (b)(6) and rvad removed on (b)(6) 2013. Cardiac drips have been discontinued and the pt continues on sildenafil now at 20mg po q8hrs. Rhc on (b)(6): ra 14, rv 55/15, pa 45/16/31, pcwp 15, co 6. 33. Results of rhc from today are pending. Will continue to support right ventricle sildenafil at this time. Will look at filling pressures closely to determine if augmentation in diuresis with lasix will be required if volume up balanced with recovering renal function pravastatin continues at 40mg po qhs. Bleeding seen initially post-opt has now resolved. Sc heparin continues for dvt prophylaxis while in hospital. Will continue to watch for bleeding closely. Respiratory function improved and the pt was successfully extubated on (b)(6). Now on ra with good o2 saturations. Tube feeds were discontinued on (b)(6) in preparation for extubation. Now on normal po diet and tolerating well. Nausea much improved with no zofran doses needed since (b)(6). Will continue nexium po for gi ppx. Now transitioned to hd for support of renal function. Uop continues to improve and now with decreasing bun and scr demonstrating evidence of further recovery and return of renal function. Has not required dialysis since 5(b)(6) and now anticipating no more sessions will be required and plan to d/c dialysis access tomorrow on (b)(6) 2013. Medications have been adjusted at this time and will require further adjustments with recovering renal function. Id: parvovirus b19 suspected for initial myocarditis and development of cardiomyopathy. Last detected by pcr in (b)(6) 2012. Repeat pcr was sent on (b)(6) and showed low (but positive) parvo viral load. Parvovirus pcr resent on (b)(6). Will follow-up with id as to further treatment if required. Cmv negative with cmv positive donor receiving induction immunotherapy with thymoglobulin. Pt now on valganciclovir 450 mg q monday and thursday. Will follow renal function and marrow indices closely for potential increase in dose. Clotrimazole troches begun on (b)(6) for anti-fungal prophylaxis. Septra ss begun on (b)(4) for pcp prophylaxis. All other treatment antibiotics have been discontinued. Endocrine now has been converted to insulin ss for glycemic control. Tacrolimus level today was 8. 3 ng/ml. Tacrolimus dose now at 4 mg po q12hrs. Will continue to follow tacrolimus levels closely. Cellcept continues at a dose (b)(6): ishlt grade 1b, ea 0, immuno negative. Tentatively planning to decrease prednisone dose further to 15mg bid if biopsy results from today are okay. Planning for potential d/c.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037028
MDR Report Key3913215
Date Received2014-06-27
Date of Report2014-06-26
Date of Event2013-04-29
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, 1 L
Product CodeMSB
Date Received2014-06-27
Lot NumberCE-307-01
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerSANOFI-AVENTIS


Patients

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

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