FDA Adverse Event
Death
Summary report: N
LEVEL 1
MDR report key: 1840807
·
Received September 15, 2010
Report
- Report Number
- 1840807
- Event Type
- Death
- Date Received
- September 15, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 15, 2010
- Manufacturer
- SMITHS MEDICAL NORTH AMERICA
- Product Code
- KZD
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
PATIENT WITH PAST MEDICAL HISTORY SIGNIFICANT FOR MARFAN SYNDROME, S/P STATUS POST AVR ACCELERATED VENTRICULAR RHYTHM AND AORTIC ARCH ANEURYSM REPAIR, VSD VENTRICULAR SEPTAL DEFECT CLOSURE, WITH NON-ISCHEMIC CARDIOMYOPATHY WITH SEVERE LEFT VENTRICULAR DYSFUNCTION WITH EJECTION FRACTION 15%, S/P STATUS POST ICD IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IMPLANTATION. PATIENT WAS UNDERGOING RE-DO AORTIC ARCH ANEURYSM REPAIR. DURING THE SURGERY, PATIENT BECAME HYPOTENSIVE, CONVERTING TO JUNCTIONAL RHYTHM. TEE TRANSESOPHAGEAL CARDIOGRAPHY DEMONSTRATED INTRACARDIAC AIR. PATIENT COULD NOT BE RESUSCITATED AND DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEL 1 | FLUID WARMER AND RAPID INFUSER | KZD | SMITHS MEDICAL NORTH AMERICA | H-250 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death | NO OTHER THERAPIES |