MULTIFILTRATE PRO MACHINE
Report
- Report Number
- 0001225714-2023-00063
- Event Type
- Malfunction
- Date Received
- August 3, 2023
- Date of Event
- July 19, 2023
- Report Date
- September 14, 2023
- Manufacturer
- SCHWEINFURT
- Product Code
- KDI
- PMA / PMN Number
- EUA200149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
CORRECTION PROVIDED IN H6.
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.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE HAD A BANG, TURNED OFF, AND COULD NOT BE RESTARTED DURING A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). THE MACHINE SMELLED SCORCHED. THE PATIENT¿S TREATMENT WAS CONTINUED ON ANOTHER DEVICE. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED 246 ML OF BLOOD LOSS. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. ON JULY 20, 2023, AN ONSITE SERVICE TECHNICIAN WAS ABLE TO RESTART THE MACHINE WITH NO FOUL ODOR AND NO SIGNS OF A SHORT CIRCUIT. THERE WERE PARTS OF THE HOSE STILL HANGING ON THE DEVICE. A 9040 ERROR CODE WAS NOTED ON THE ERROR MEMORY READOUT WHICH LED TO THE SYSTEM CRASH OF THE MACHINE. UPON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO OTHER COMPONENTS, NO SMOKE DETECTORS WENT OFF AND THE USE OF A FIRE EXTINGUISHER OR EVACUATION WAS NEEDED. THE MACHINE COULD BE STARTED NORMALLY AND A SELF-TEST RAN WITHOUT ERROR MESSAGES. AS A RESULT, NO MACHINE FAULT COULD BE DETECTED AND NO REPAIRS HAVE BEEN PERFORMED.
IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE HAD A BANG, TURNED OFF, AND COULD NOT BE RESTARTED DURING A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). THE MACHINE SMELLED SCORCHED. THE PATIENT¿S TREATMENT WAS CONTINUED ON ANOTHER DEVICE. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED 246 ML OF BLOOD LOSS. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. ON (B)(6), 2023, AN ONSITE SERVICE TECHNICIAN WAS ABLE TO RESTART THE MACHINE WITH NO FOUL ODOR AND NO SIGNS OF A SHORT CIRCUIT. THERE WERE PARTS OF THE HOSE STILL HANGING ON THE DEVICE. A 9040 ERROR CODE WAS NOTED ON THE ERROR MEMORY READOUT WHICH LED TO THE SYSTEM CRASH OF THE MACHINE. UPON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO OTHER COMPONENTS, NO SMOKE DETECTORS WENT OFF AND THE USE OF A FIRE EXTINGUISHER OR EVACUATION WAS NEEDED. THE MACHINE COULD BE STARTED NORMALLY AND A SELF-TEST RAN WITHOUT ERROR MESSAGES. AS A RESULT, NO MACHINE FAULT COULD BE DETECTED AND NO REPAIRS HAVE BEEN PERFORMED.
IT WAS REPORTED THAT A MULTIFILTRATE PRO MACHINE HAD A BANG, TURNED OFF, AND COULD NOT BE RESTARTED DURING A PATIENT¿S CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD). THE MACHINE SMELLED SCORCHED. THE PATIENT¿S TREATMENT WAS CONTINUED ON ANOTHER DEVICE. THE PATIENT¿S BLOOD WAS NOT RETURNED, AND AS A RESULT THEY EXPERIENCED 246 ML OF BLOOD LOSS. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. ON JULY 20, 2023, AN ONSITE SERVICE TECHNICIAN WAS ABLE TO RESTART THE MACHINE WITH NO FOUL ODOR AND NO SIGNS OF A SHORT CIRCUIT. THERE WERE PARTS OF THE HOSE STILL HANGING ON THE DEVICE. A 9040 ERROR CODE WAS NOTED ON THE ERROR MEMORY READOUT WHICH LED TO THE SYSTEM CRASH OF THE MACHINE. UPON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO OTHER COMPONENTS, NO SMOKE DETECTORS WENT OFF AND THE USE OF A FIRE EXTINGUISHER OR EVACUATION WAS NEEDED. THE MACHINE COULD BE STARTED NORMALLY AND A SELF-TEST RAN WITHOUT ERROR MESSAGES. AS A RESULT, NO MACHINE FAULT COULD BE DETECTED AND NO REPAIRS HAVE BEEN PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1657575 | MULTIFILTRATE PRO MACHINE | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | SCHWEINFURT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |