FDA Adverse Event
Malfunction
Summary report: N
POLYFLUX
MDR report key: 22495613
·
Received July 14, 2025
Report
- Report Number
- 9611369-2025-00097
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 4, 2025
- Report Date
- August 1, 2025
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Product Code
- FJI
- UDI-DI
- 07332414086633
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: H6, H11 H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE "INTERFACE" OF A POLYFLUX 14L HALF AN HOUR AFTER THE START OF HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485174 | POLYFLUX | DIALYZER, CAPILLARY, HOLLOW FIBER | FJI | VANTIVE US HEALTHCARE LLC | NA | 5-5109-H-01 | 07332414086633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |