FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 3847826
·
Received May 19, 2014
Report
- Report Number
- 1225714-2014-02879
- Event Type
- Death
- Date Received
- May 19, 2014
- Date of Event
- August 15, 2011
- Report Date
- April 21, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR #1225714-2014-02878.
Additional Manufacturer Narrative · 1
(B)(4): (ALKALOSIS). THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT ASSOCIATED MFR REPORT #S 1225714-2014-02878 AND 1225714-2014-02879. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
AL 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.
Description of Event or Problem · 1
THE PLAINTIFF ATTORNEY ALLEGED THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY AND SUBSEQUENTLY EXPIRED ON AN UNK DATE AFTER USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296990 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |