FDA Adverse Event
Malfunction
Summary report: N
NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
MDR report key: 23138196
·
Received September 24, 2025
Report
- Report Number
- 1056186-2025-00019
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- November 19, 2024
- Report Date
- September 24, 2025
- Manufacturer
- SHIBUYA (SBY)
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CUSTOMER STATED THAT SCREW FELL OUT OF THE BLOOD PUMP ROTOR WHILE SETTING THE MACHINE UP FOR A PATIENT TREATMENT. MACHINE WAS PULLED FROM THE TREATMENT FLOOR. MACHINE INSTALLED (B)(6) 2024, MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 2209HRS. (B)(6) 2024: NATIONAL SERVICE ENGINEER FOUND THAT THE ADJUSTMENT SCREW HAD BACKED ITSELF ALL THE WAY OUT OF THE BLOOD PUMP ROTOR. BLOOD PUMP ASSEMBLY REPLACED. ALL FUNCTIONAL TESTS PERFORMED. PERFORMED SIMULATED UF TREATMENT, NO ERRORS OR ABNORMALITIES OBSERVED. MACHINE OPERATES PER MANUFACTURER SPECIFICATIONS AND READY FOR PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2393978 | NIPRO SURDIAL DX HEMODIALYSIS SYSTEM | DIALYSIS MACHINE | KDI | SHIBUYA (SBY) | MC+SDX01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |