FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY
MDR report key: 4230790
·
Received October 24, 2014
Report
- Report Number
- 1713747-2014-00526
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 26, 2014
- Report Date
- September 26, 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 HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED. TEST STRIPS WERE NOT USED TO CONFIRM AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 300 ML. THE PT HAD NO REQUIRED ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PT COMPLETED TREATMENT WITH A NEW SET-UP. SAMPLE HAS BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677985 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 14DU04011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | FRESENIOUS 2008K2 HEMODIALYSIS MACHINE |