FDA Adverse Event
Death
Summary report: N
ABL80 FLEX CO-OX ANALYZER
MDR report key: 1908074
·
Received November 10, 2010
Report
- Report Number
- 2027541-2010-00004
- Event Type
- Death
- Date Received
- November 10, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 20, 2010
- Manufacturer
- SENDX MEDICAL, INC.
- Product Code
- CHL
- PMA / PMN Number
- K080370
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION OF THIS EVENT IS CURRENTLY UNDERWAY. IT IS UNCLEAR IF THE POTASSIUM RESULT IS RELATED TO THE PATIENT'S DEATH. ALL CALIBRATION AND QUALITY CONTROL RESULTS WERE WELL WITHIN ACCEPTABLE RANGES AROUND THE TIME OF THE INCIDENT. WHEN THE SERVICE ENGINEER INSPECTED THE INSTRUMENT, EVERYTHING APPEARED NORMAL.
Description of Event or Problem · 1
A BURNS PATIENT IN THE OPERATING ROOM DIED AFTER DOCTORS ACTED ON A POTASSIUM LEVEL OF 15.8 MMOL/L. THE PATIENT WAS ON SILVER NITRATE, INSTILLED UNDER PRESSURE BY THE BLADDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABL80 FLEX CO-OX ANALYZER | PH, BLOODGAS, ELECTROLYTE ANALYSIS SYSTEM | CHL | SENDX MEDICAL, INC. | 393-841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death |