FDA Adverse Event
Injury
Summary report: N
U0308 XENIUM 210G SYNTH HFDIALYZER
MDR report key: 1243945
·
Received November 25, 2008
Report
- Report Number
- 1423500-2008-00936
- Event Type
- Injury
- Date Received
- November 25, 2008
- Date of Event
- November 5, 2008
- Report Date
- November 7, 2008
- Manufacturer
- NIPRO CORPORATION
- Product Code
- FKX
- PMA / PMN Number
- K062079
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS DISCARDED AND NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE FACILITY REPORTED THAT A PATIENT EXPERIENCED ABDOMINAL PAIN + VOMITING ONE HOUR INTO THE DIALYSIS THERAPY USING A XENIUM DIALYZER (DATE UNKNOWN). THE PATIENT WAS SEEN BY A CONSULTANT. THE NEXT MORNING THE BLOOD SAMPLES WERE GROSSLY HAEMOLYSED (HEMOLYSIS). A DIAGNOSIS OF HAEMOLYSIS (HEMOLYSIS) WAS MADE. REPORTEDLY THERE WAS NO EVIDENCE OF HAEMOLYSIS (HEMOLYSIS) APPARENT IN THE BLOODLINES OR DIALYZER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U0308 XENIUM 210G SYNTH HFDIALYZER | 78FKX | FKX | NIPRO CORPORATION | 08F05S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |