FDA Adverse Event
Malfunction
Summary report: N
NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
MDR report key: 23151712
·
Received September 25, 2025
Report
- Report Number
- 1056186-2025-00031
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Date of Event
- June 4, 2025
- Report Date
- September 25, 2025
- Manufacturer
- SHIBUYA (SBY)
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REPORTED CONDITION: FRONT ROTOR PANEL SCREW IS MISSING. THE NATIONAL SERVICE ENGINEER REPLACED MISSING FRONT PANEL SCREW ON ROTOR. AFTER INSTALLATION, VERIFIED THAT ALL COMPONENTS ARE SECURE AND THE UNIT IS OPERATING CORRECTLY PER MANUFACTURING SPECIFICATIONS. MACHINE INSTALLED (B)(6) 2024, MACHINE RUN HOURS AT TIME OF EVENT 3212HRS. (B)(6) 2025: THE NATIONAL SERVICE ENGINEER REPLACED MISSING FRONT PANEL SCREW ON ROTOR. AFTER INSTALLATION, VERIFIED THAT ALL COMPONENTS ARE SECURE AND THE UNIT IS OPERATING CORRECTLY PER MANUFACTURING SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303984 | NIPRO SURDIAL DX HEMODIALYSIS SYSTEM | DIALYSIS MACHINE | KDI | SHIBUYA (SBY) | MC+SDX01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |