FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 5109716
·
Received September 25, 2015
Report
- Report Number
- 1225714-2015-07512
- Event Type
- Death
- Date Received
- September 25, 2015
- Date of Event
- February 13, 2007
- Report Date
- September 16, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K981043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)- ALKALOSIS. THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. 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 ALKALOSIS, CARDIAC ARRHYTHMIAS, SUDDEN CARDIAC ARREST AND SUDDEN CARDIAC DEATH. IT WAS FURTHER ALLEGED THE EVENT WAS CAUSED BY THE PRODUCT ADMINISTERED TO THE PATIENT DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637249 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |