FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4252671
·
Received November 13, 2014
Report
- Report Number
- 1225714-2014-14780
- Event Type
- Death
- Date Received
- November 13, 2014
- Date of Event
- November 6, 2007
- Report Date
- October 30, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS.
Additional Manufacturer Narrative · 1
(B)(4). THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT. 1225714-2014-14780; 1225714-2014-14781.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED ALKALOSIS, CARDIAC ARRHYTHMIAS, SUDDEN CARDIAC ARREST, AND SUDDEN CARDIAC DEATH AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT. THE ALLEGED EVENT OCCURRED DUE TO THE ADMINISTRATION OF THE PRODUCT FOR DIALYSIS TREATMENT.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURIES AND SUBSEQUENTLY EXPIRED ON AN UNK DATE AFTER USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733431 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |