MULTIFILTRATE PRO MACHINE
Report
- Report Number
- 0001225714-2023-00061
- Event Type
- Malfunction
- Date Received
- August 2, 2023
- Date of Event
- June 16, 2023
- Report Date
- September 11, 2023
- Manufacturer
- SCHWEINFURT
- Product Code
- KDI
- PMA / PMN Number
- EUA200149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- 003
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
ADDITIONAL INFORMATION PROVIDED IN B5 AND D10.
PLANT INVESTIGATION: THE REVIEW OF THE COMPLAINTS REVEALED THAT THE REPORTED FAILURE TYPE REPRESENTS A KNOWN EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS FOUND TO BE NOT NEEDED DUE TO THE FACT THAT THE FAILURE/COMPLAINT CAN BE CLEARLY ATTRIBUTED TO THE FAILURE MODE DESIGN. BASED ON ALL PERFORMED INVESTIGATIONS/EVALUATIONS THE DESCRIBED BEHAVIOR COULD BE REPRODUCED. THE 9040.1 ERROR CODE IS A COLLECTIVE ERROR CODE FOR ALL KINDS OF PGM (POISSON, GAUSSIAN, AND MULTIPLICATIVE) MISCALCULATION. THERE ARE MANY SOURCES OF PGM ERROR. PGM ERRORS RESULT IN THE DESCRIBED 9040.1 ERROR ON THE DIALYSIS MACHINE. AS THIS TYPE OF PGM ERROR CAN BE CAUSED BY DIFFERENT CAUSES, THERE IS CURRENTLY NOT A SINGLE ROOT CAUSE. A 9040.1 ERROR USUALLY LEADS TO THE TERMINATION OF THE TREATMENT AND TO THE STOP OF THE MACHINE. AFTER RESTARTING THE DEVICE, THE TREATMENT COULD BE CONTINUED. MANUAL BLOOD REINFUSION SHOULD ALWAYS BE POSSIBLE AND IS DESCRIBED IN INSTRUCTIONS FOR USE (IFU). THE 9040.1 ERROR IS CONSIDERED WITHIN THE SCOPE OF THE PRODUCT IMPROVEMENT. NO HARDWARE COMPONENT IS ASSOCIATED WITH THIS COMPLAINT THEREFORE, NO HARDWARE/SAMPLE INVESTIGATION WAS PERFORMED. THERE ARE NO INDICATIONS ON THE BASIS OF RECEIVED COMPLAINT INFORMATION AND ALL INVESTIGATIONS THAT THE PRODUCT DEFICIENCY IS RELATED TO FALSIFICATION OR AN UNAUTHORIZED CONFIGURATION. THE RESIDUAL RISK IS BROADLY ACCEPTABLE.
IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE HAD A SUDDEN PERSISTENT SYSTEM ERROR 9040.1 ONE HOUR INTO A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). THE SYSTEM SHUT DOWN. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED APPROXIMATELY 200 ML OF BLOOD LOSS. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN OBTAINED.
ADDITIONAL INFORMATION PROVIDED CONFIRMS THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. THE TECHNICIAN PERFORMED A FUNCTIONAL TEST THAT SHOWED A 9040.1 ERROR OCCURRED AT 22:00 HOURS INTO TREATMENT. IT IS UNKNOWN IF THE PATIENT¿S PROCEDURE WAS RESTARTED AND COMPLETED. THE MACHINE IS FULLY OPERATIONAL.
ADDITIONAL INFORMATION PROVIDED CONFIRMS THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. THE TECHNICIAN PERFORMED A FUNCTIONAL TEST THAT SHOWED A 9040.1 ERROR OCCURRED AT 22:00 HOURS INTO TREATMENT. IT IS UNKNOWN IF THE PATIENT¿S PROCEDURE WAS RESTARTED AND COMPLETED. THE MACHINE IS FULLY OPERATIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740760 | MULTIFILTRATE PRO MACHINE | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | SCHWEINFURT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | MULTIFILTRATEPRO SECUKIT CI-CA HD 1000| MULTIFILTRATEPRO SECUKIT CI-CA HD 1000 |