FDA Adverse Event
Malfunction
Summary report: N
NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
MDR report key: 23140026
·
Received September 24, 2025
Report
- Report Number
- 1056186-2025-00023
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- July 3, 2025
- Report Date
- September 24, 2025
- Manufacturer
- SHIBUYA (SBY)
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REPORTED CONDITION: BIOMED REPORT SCREW MISSING FOR ROTOR ASSY AND FLAT HEAD SCREW ON ARM COVER. ARM COVER LOOSE. UNABLE TO FIND SCREWS. MACHINE INSTALLED (B)(6) 2024 MACHINE TOTAL RUN HOURS AT THE TIME OF EVENT WAS 1115HRS. (B)(6) 2025: NATIONAL SERVICE ENGINEER REPLACED WITH A NEW BLOOD PUMP ASSEMBLY. MACHINE IS OPERATING TO MANUFACTURERS SPECIFICATIONS. READY FOR PATIENT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2394096 | NIPRO SURDIAL DX HEMODIALYSIS SYSTEM | DIALYSIS MACHINE | KDI | SHIBUYA (SBY) | MC+SDX01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |