MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-27 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..
[4834090]
This unsolicited device case from united states was received on (b)(6) 2014 from pharmacist via food and drug administration (regulatory reference number: (b)(4)). This case involves a (b)(6) year old male patient who developed acute right heart failure, refractory coagulopathy, acute respiratory failure, hi-ventricular failure, no cardiac activity demonstrated, acute lung injury and later died after undergoing heart transplant which were preserved with celsior organ preservation solution (celsior) (off label use). The patient's medical history was significant for ischemic cardiomyopathy with systolic heart failure (1995), myocardial infarction (cabg in 1995) and hypothyroidism. Concomitant medications reported include milrinone, propofol as sedation, morphine as analgesia, esomeprazole (nexium) for gi (gastrointestinal) prophylaxis, vancomycin, piperacillin sodium/tazobactam sodium (zosyn) and fluconazole as preventive therapy, ganciclovir for cmv (cytomegalovirus) prophylaxis, anti-thymocyte globulin (rabbit) (thymoglobulin), insulin for glycemic control, levothyroxine sodium (synthroid), heparin, mycophenolate mofetil (cellcept) and methylprednisolone. No past drugs and concurrent on an unknown date in 2013, the heart for transplant was preserved in celsior, solution for organ preservation (batch/lot number: ce-307-01 and expiration date: unknown). On an unknown date in 2013, the patient was subsequently transplanted. The other factors pre transplant included previous sternotomy for cabg (coronary artery bypass) and coumadin therapy. On day post operation day 7 from heart transplant, the transplant was complicated by intra-operative acute right heart failure requiring placement of rvad (right ventricular assist device), refractory coagulopathy requiring administration of multiple blood products, factor ix complex human (profilnine) and factor vii (proconvertin) (factor vii), post-operation 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 (extracorporeal membrane oxygenation), the patient was cmv+ and donor cmv-. The patient was taken to operating room for mediastinal exploration/washout, movement of ecmo venous cannula was placed to left femoral vein and partial wound closure was done with placement of wound vac. The central line was changed. The patient continued sedation with propofol and analgesia with morphine drip. The patient also continued to cardiopulmonary support with v/a ecmo and attempted to wean norepinephrine, vasopressin, and neosynephrine as tolerated to support map. The patient continues with acute lung injury secondary most likely to massive transfusion requirements. The patient was supported with v/a ecmo and attempted to remove volume with cwhd (continuous venous- venous hemodialysis} when able to aid with lung recovery. The tube feeds were held again and the am for line changed. The patient continues on cwhd for crrt (continuous renal replacement therapy). The potassium was marginally controlled. The patient was continued to follow closely and medications were adjusted accordingly to account for removal with cwhd. Antimicrobials included vancomycin, piperacillin sodium/tazobactam sodium and fluconazole for pre-emptive therapy for open chest in highly immunosuppressed patient with mechanical circulatory support device, and ganciclovir forcmv prophylaxis with use of induction therapy with thymoglobulin. Pcp prophylaxis with bactrim was to be continued at a later time. Initiation of statin therapy was to be considered in the future. The patient had thrombus in oxygenator and fibrin streaking in the ecmo cannula. Heparin drip was initiated for re-exploration and washout. It was re-initiated at lower dose in evening with planned titration for aptt of 80-90 seconds. Heparin drip discontinued for procedure but subsequently restarted at 6 units/kg/hr. The patient was followed for hemostasis issues and ecmo circuit was observed very closely. The cd3 counts were monitored and redose of anti-thymocyte globulin (rabbit) was administered for cd3 counts greater than 25 cells/ul for induction and calcineurin inhibitors were withheld with compromised renal function. A transesophageal echocardiogram was performed on post operative day 8 which did not demonstrate any cardiac activity. Thus, the patient was continued on extracorporeal membrane oxygenation. On the morning of postoperative day 11, the nurses evaluated him and noticed that the patient had a fixed and dilated pupil on the left and had lost corneal reflex on that side. The patient no longer had a gag reflex. On an unknown date, the patient expired. It was unknown whether autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5
[12354312]
A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criterion: hospitalization for all events pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this case concerns a patient who experienced the events of acute right heart failure, acute respiratory failure, acute lung injury, hi-ventricular failure and cardiac arrest after receiving a heart transplant in which celsior has been used as organ preservation solution. Although the contributory role of celsior cannot be denied from the occurence of these events, however, as no adequate clinical studies have been performed in pediatric patients it is difficult to make a complete case assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2014-14770 |
| MDR Report Key | 4100913 |
| Report Source | 05 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-19 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2014-08-19 |
| Date Added to Maude | 2014-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL MURPHY |
| Manufacturer Street | 55 CORPORATE DRIVE MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089813633 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2014-08-27 |
| Lot Number | CE-307-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Address | LYON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2014-08-27 |