FDA Adverse Event
Death
Summary report: N
COBE CENTRYSYSTEM 3
MDR report key: 293550
·
Received August 31, 2000
Report
- Report Number
- 1713683-2000-00021
- Event Type
- Death
- Date Received
- August 31, 2000
- Date of Event
- July 31, 2000
- Report Date
- August 1, 2000
- Manufacturer
- GAMBRO RENAL PRODUCTS
- Product Code
- FII
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
PATIENT #3. APPROXIMATELY TWO HOURS INTO THE TREATMENT, THE PT BECAME HYPOTENSIVE AND WAS PLACED IN THE TRENDELENBURG POSITION AND ADMINISTERED OXYGEN AND SALINE. THE PT CONTINUED TO COMPLAIN OF NOT FEELING WELL AND OF FEELING SWEATY; AN ADDITIONAL 100 CC SALINE WAS ADMINISTERED. AN HOUR LATER THE TREATMENT WAS TERMINATED AND SHAKING AND VOMITING WAS NOTED. THE PT CONTINUED TO COMPLAIN OF NOT FEELING WELL AND WAS ADMITTED TO THE HOSP ON JULY 31, 2000. THE PT EXPIRED IN THE ICU SHORTLY AFTER MIDNIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBE CENTRYSYSTEM 3 | DIALYSIS CONTROL UNIT | FII | GAMBRO RENAL PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |