FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5088185
·
Received September 17, 2015
Report
- Report Number
- 1225714-2015-07452
- Event Type
- Death
- Date Received
- September 17, 2015
- Date of Event
- April 19, 2012
- Report Date
- September 4, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED RAPIDLY DECLINING BLOOD PRESSURE, CARDIO PULMONARY FAILURE, BACTEREMIA, SEPSIS AND EXPIRED THE SAME DAY, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614909 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |