FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 3202169
·
Received June 28, 2013
Report
- Report Number
- 1713747-2013-00238
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PLANT INVESTIGATION IS CURRENTLY ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED AT THE BEGINNING OF TREATMENT. NO DAMAGE WAS IDENTIFIED OR OTHER LEAKS. BLOOD TEST STRIPS WERE USED, AND THE MACHINE ALARMED. PT WAS ESTIMATED TO LOSE GREATER THAN 100 CC OF BLOOD; HOWEVER, THE PT HAD NO ADVERSE EFFECTS DUE TO LEAK COMPLICATIONS. AFTER TREATMENT THE DIALYZER WAS THROWN AWAY. NO SAMPLE. BLOOD FLOW RATE - 550; DIALYSATE FLOW RATE - 1.5X AUTOFLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296613 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | OPTIFLUX 180NRE DIALYZER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | K MACHINE |