INTERGRATED APD SET
Report
- Report Number
- 2314912-2025-00903
- Event Type
- Malfunction
- Date Received
- August 29, 2025
- Date of Event
- August 4, 2025
- Report Date
- October 1, 2025
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Product Code
- FKX
- UDI-DI
- 00085412090078
- PMA / PMN Number
- K102936
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION: H6 AND 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 DEVICES WERE DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION MADE TO B5: IT WAS REPORTED THAT THE CAP OF THE PATIENT LINE OF AN UNSPECIFIED QUANTITY [PREVIOUSLY SUBMITTED AS FOUR (4) OF HOMECHOICE CASSETTES WAS SEPARATED. H11: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE CAP OF THE PATIENT LINE OF FOUR (4) HOMECHOICE CASSETTE WAS SEPARATED. THIS OCCURRED DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS 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 |
|---|---|---|---|---|---|---|---|
| 2163173 | INTERGRATED APD SET | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | VANTIVE US HEALTHCARE LLC | NA | H25E05074 | 00085412090078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |