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

[4516509] A (b)(6) male with pmh significant for nonischemic dilated cardiomyopathy, asthma, and vt. He received an ohtx on (b)(6) 2014. The case was complicated by primary graft failure requiring biventricular mechanical support with centrimags. Pt developed significant coagulopathy intraoperatively and post-operatively requiring multiple doses of recombinant factor viia (8 mg total) and pcc (7500 units total). He was taken back to the operating room for a washout on (b)(6) due to persistent bleeding. He was taken to the operating room again for another washout and evaluation of the heart function on (b)(6), lvad was removed. Pt then taken back for washouts on (b)(6). Rvad removed on (b)(6) and pt has a closed chest. Pt underwent rhc and endomyocardial biopsy and subsequently extubated on (b)(6). Cvvh converted to hd on (b)(6) 2013. Repeat rhc/biopsy on (b)(6). Transfer to floor on (b)(6) 2014. Rhc and biopsy on (b)(6). Debridement by plastic surgery of full thickness infiltration injury to right foot secondary to methylene blue infiltration and placement of wound vac on (b)(6) 2014. Rhc/bx on (b)(6) 2014 with discharge to acute rehab to follow. Pod#47 from orthotopic heart transplant with pgd requiring placement of bivad. Neuro: awake, alert, and fully intact responding appropriately to commands. Had formal debridement by plastic surgery of full thickness infiltration injury to right foot secondary to methylene blue infiltration on (b)(6) 2014 and placement of wound vac. Pt experiencing significant increase in pain with this procedure especially with wound vac changes but has improved over last several days. He is now on scheduled oxycontin and oxycodone prn for pain. He continues on benadryl 25 mg po hs prn for sleep and citalopram 20 mg po daily respectively. Pt with significant deconditioning from critical illness. Working with pt and ot and continues to show improvement and now walking with assistance. Plan to discharge pt today acute rehab after rhc and bx for continued reconditioning at this time. Plastics to continue to follow for wound vac changes and progress. Cv: lvad removed on (b)(6), rvad removed on (b)(6). Milrinone weaned off on (b)(6). Rhc and biopsy on (b)(6) as follows: ra 8, rv 33/10, pa 33/10/18, pcwp 10, co/ci (thermodilution) 4. 6/2. 2, pa sat 52%, cellular bx score 0, ea 0. These results are markedly improved from (b)(6) and now with normal lft's and evidence of good perfusion on physical exam. Rhc with bx today as continued f/u and surveillance for acute rejection. Will need f/u on these results. Will continue to follow closely and continue volume maintenance with hd. With increased but now normalized lft's will continue to hold pravastatin and continue aspirin 81 mg daily. Pulm: extubated on (b)(6) and now on ra with good saturations. Fengi: abdominal exam is normal at this time with normal lft's. Hepatology suspects potential drug toxicity which may have included amiodarone, statin or clotrimazole. These meds have been discontinued. Will continue nexium 40 mg po daily, colace and senna for bowel regimen while on increased doses of narcotics for pain control. Renal: converted to hd on (b)(6) and continues now on a qod basis at this time for fluid and electrolyte maintenance. Also continues on sevelamer 1600 mg po tid for phosphate control. Medications have been adjusted in accordance with present mode of renal replacement. Will continue to follow for evidence of improvement and recovery of renal function. Id: pt continues to be afebrile. Noted to have dysuria with subsequent positive u/a and urine culture growing p. Aeruginosa susceptable to ciprofloxacin. Ciprofloxacin 500 mg po daily started for treatment of uti and discontinued on (b)(6) 2014 after 7 day course of treatment. Repeat urine culture from 3/3 pending and will require f/u. Cmv igg + (donor cmv igg+) in addition to cytolytic therapy - pt continues on valganciclovir 450 mg po qm, th. Pcp prophylaxis with septra ss qm, w,f and antifungal prophylaxis now continues with nystatin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037027
MDR Report Key3913211
Date Received2014-06-27
Date of Report2014-06-26
Date of Event2014-01-16
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 PRESERVATION FOR HEART TRANSPLANT, 1 L
Product CodeMSB
Date Received2014-06-27
Lot NumberCE-370-02
Device AvailabilityY
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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