FDA Adverse Event
Injury
Summary report: N
ASAHI DIALYZERS AM-NR
MDR report key: 263682
·
Received February 17, 2000
Report
- Report Number
- 8010002-2000-00007
- Event Type
- Injury
- Date Received
- February 17, 2000
- Date of Event
- January 25, 2000
- Report Date
- February 14, 2000
- Manufacturer
- ASAHI MEDICAL CO., LTD.
- Product Code
- FJI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS ADVERSE EVENT OCCURRED AT ANOTHER FACILITY. THIS FACILITY CHANGED DIALYZERS FROM THE FRESENIUS F-SERIES TO AM-NR-100U FOR 187 PTS. IN THIS HOSPITAL, AM-NR-100U DIALYZERS ARE INTENDED FOR SINGLE USE ONLY PT F CONTINUED TO USE AM-NR-100U DIALYZERS WITHOUT ANY PROBLEM FOR 2 WEEKS. AFTER THAT THIS TIMEFRAME, PT FELT FUNNY ANY BECAME FAINT 7 OR 8 MINUTES AFTER INITIATION OF TREATMENT. NO RESPIRATION OR PULSE WAS NOTED AND CPR STARTED. PT F HAS RECOVERED. CURRENTLY THERE IS NO PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASAHI DIALYZERS AM-NR | HEMODIALYZER | FJI | ASAHI MEDICAL CO., LTD. | AM-NR-100U | 19Z4ZH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Life Threatening |