FDA Adverse Event
Other
Summary report: N
CT GAMMA DIALYZER (CT 110G)
MDR report key: 301936
·
Received October 24, 2000
Report
- Report Number
- 1423500-2000-01071
- Event Type
- Other
- Date Received
- October 24, 2000
- Date of Event
- May 17, 2000
- Report Date
- September 25, 2000
- Manufacturer
- NISSHO CORP.
- Product Code
- FJI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BAXTER AFFILIATE REPORTS ONE INCIDENT OF HEMOLYSIS. 4 HOURS AFTER THE INITIATION OF THE HEMODIALYSIS SESSION, THE PT EXPERIENCED HYPERTENSIVE CRISIS (BLOOD PRESSURE 200/90) ASSOCIATED WITH NAUSEA AND VOMITING, TINNITUS. THE PT WAS HOSPITALIZED FROM 2000 TO 2000 AND HEMOLYSIS WAS DIAGNOSED. PT HAS SINCE RECOVERED. THE MACHINE IN USE AT THE TIME OF THE INCIDENT IS STILL IN USE ACCORDING TO CENTER PERSONNEL WITHOUT PROBLEMS NOTED. ALL DISPOSABLES WERE DISPOSED OF BY CENTER PERSONNEL AT THE END OF THE TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CT GAMMA DIALYZER (CT 110G) | HOLLOW FIBER DIALYZER | FJI | NISSHO CORP. | CT 110G | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| O |