FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 3963148
·
Received May 27, 2014
Report
- Report Number
- 1713747-2014-00262
- Event Type
- Malfunction
- Date Received
- May 27, 2014
- Date of Event
- May 3, 2014
- Report Date
- May 3, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 REPORTED DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE. THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 500CC. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310141 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 13PR06008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | FRESENIUS 2008K HEMODIALYSIS MACHINE |