FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4253217
·
Received November 7, 2014
Report
- Report Number
- 1225714-2014-14686
- Event Type
- Death
- Date Received
- November 7, 2014
- Date of Event
- August 26, 2005
- 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 PATIENT INVOLVING TWO SEPARATE PRODUCTS.
Additional Manufacturer Narrative · 1
PATIENT CODE: 3191 - ALKALOSIS. THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. ASSOCIATED MFR REPORT NUMBERS: 1225714-2014-14686 AND 1225714-2014-14687. 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 DECEDENT EXPERIENCED UNSPECIFIED INJURIES AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE AFTER USE OF THE PRODUCT.
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 TO THE PATIENT DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719476 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |