FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
MDR report key: 4202641
·
Received September 18, 2014
Report
- Report Number
- 1713747-2014-00463
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 27, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE 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 THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. THERE WAS A CRACK IN THE VENOUS CONNECTION IN THE HEADER. ESTIMATED BLOOD LOSS WAS 230CC'S. THE PATIENT WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS. THE PATIENT HAD NO ADVERSE EFFECTS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580857 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING | 14HU06004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | FRESENIUS 2008K MACHINE |