FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 3963362
·
Received June 19, 2014
Report
- Report Number
- 1713747-2014-00303
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 23, 2014
- Report Date
- June 4, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002277
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE. TEST STRIPS WERE NOT USED. THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 225 ML. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP. SAMPLE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359174 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 14CUO2019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | FRESENIUS 2008K HEMODIALYSIS MACHINE |