FDA Adverse Event
Malfunction
Summary report: N
OPTIFLEX 180 NR
MDR report key: 1053105
·
Received May 21, 2008
Report
- Report Number
- 1053105
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- April 16, 2008
- Report Date
- May 18, 2008
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE BLOOD LEAK ALARM WENT OFF AT INITIATION OF THE DIALYSIS TREATMENT. THE DIALYASATE FLUID WAS TESTED WITH A BLOOD REAGENT STRIP, WHICH WAS FOUND TO BE POSITIVE FOR A BLOOD LEAK. THE DIALYZER WITH THE BLOOD WAS DISCARDED AND THE DIALYSIS MACHINE WAS PULLED FROM SERVICE. THE DIALYSIS MACHINE WAS BLEACHED, AND A NOTE WAS LEFT FOR THE MAINTENANCE PERSONNEL AS TO THE PROBLEM. THE MANUFACTURER IS IN THE PROCESS OF INVESTIGATING THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIFLEX 180 NR | DIALYZER | KDI | FRESENIUS MEDICAL CARE NORTH AMERICA | 2008K | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |