FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 4252682
·
Received November 13, 2014
Report
- Report Number
- 1225714-2014-14793
- Event Type
- Death
- Date Received
- November 13, 2014
- Date of Event
- November 3, 2011
- Report Date
- October 30, 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) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS.
Additional Manufacturer Narrative · 1
(B)(4). THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT, THE ASSOCIATED MFR REPORT NUMBERS ARE 1225714-2014-14792 AND 1225714-2014-14793. 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 UNK 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 DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732719 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |