FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4252689
·
Received November 13, 2014
Report
- Report Number
- 1225714-2014-14790
- Event Type
- Death
- Date Received
- November 13, 2014
- Date of Event
- January 20, 2011
- 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 1225714-2014-14790 AND 1225714-2014-14791. UPON RECEIPT OF ADDITIONAL INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED ALKALOSIS, CARDIAC ARRHYTHMIAS, SUDDEN CARDIAC ARREST, AND SUDDEN CARDIAC DEATH, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED DURING 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 |
|---|---|---|---|---|---|---|---|
| 733450 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |