NIPRO BLOOD TUBING SET W/TP
Report
- Report Number
- 8041145-2024-00001
- Event Type
- Malfunction
- Date Received
- February 6, 2024
- Date of Event
- December 21, 2023
- Report Date
- February 12, 2024
- Manufacturer
- NIPRO (THAILAND) CORP. LTD.
- Product Code
- FJK
- UDI-DI
- 00383790008808
- PMA / PMN Number
- K072024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT WAS PREVIOUSLY SUBMITTED WITH THE INCORRECT MANUFACTURER REGISTRATION NUMBER.
THIS REPORT WAS PREVIOUSLY SUBMITTED WITH THE INCORRECT MANUFACTURER REGISTRATION NUMBER.
DURING DIALYSIS TREATMENT, MACHINE ALARMED INSTANTLY FOR BLOOD LEAK WITHIN THE DIALYZER, VISIBLE IN THE ARTERIAL COUPLER TUBING. PATIENT WAS REMOVED FROM THE MACHINE WITHOUT RETURNING THE PATIENT'S BLOOD (APPROXIMATELY 250ML OF BLOOD LOSS) . PER CHARGE NURSE, PATIENT REQUIRED NO FOLLOW UP OR TRANSFUSION POST INCIDENT. DIALYZER USED: F250 DIALYZER MACHINE: SURDIAL DX HEMODIALYSIS SYSTEM PRODUCTG CODE: MC+SDX01 510K: K182940
DURING DIALYSIS TREATMENT, MACHINE ALARMED INSTANTLY FOR BLOOD LEAK WITHIN THE DIALYZER, VISIBLE IN THE ARTERIAL COUPLER TUBING. PATIENT WAS REMOVED FROM THE MACHINE WITHOUT RETURNING THE PATIENT'S BLOOD (APPROXIMATELY 250ML OF BLOOD LOSS). PER CHARGE NURSE, PATIENT REQUIRED NO FOLLOW UP OR TRANSFUSION POST INCIDENT. DIALYZER USED: F250 DIALYZER. MACHINE: SURDIAL DX HEMODIALYSIS SYSTEM. "PRODUCT" CODE: MC+SDX01. 510K: K182940.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1365147 | NIPRO BLOOD TUBING SET W/TP | BLOODLINE | FJK | NIPRO (THAILAND) CORP. LTD. | BL+A430/V912 | 22C18 | 00383790008808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |