FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 3840735
·
Received May 13, 2014
Report
- Report Number
- 1225714-2014-02547
- Event Type
- Death
- Date Received
- May 13, 2014
- Date of Event
- July 26, 2011
- Report Date
- April 17, 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 FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR # 1225714-2014-02548.
Additional Manufacturer Narrative · 1
(B)(4). THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT. ASSOCIATED MFR REPORT #S 1225714-2014-02547 AND 1225714-2014-02548. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE AFTER USE OF THE PRODUCT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED ALLEGED 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285331 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |