MULTIFILTRATE PRO MACHINE
Report
- Report Number
- 0001225714-2025-00002
- Event Type
- Malfunction
- Date Received
- January 27, 2025
- Date of Event
- January 13, 2025
- Report Date
- May 19, 2025
- Manufacturer
- SCHWEINFURT
- Product Code
- KDI
- PMA / PMN Number
- EUA200149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
INVESTIGATION: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY REVIEW (DHR) IS FOUND TO BE NOT NECESSARILY 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 ALARM CODE IS A COLLECTIVE ALARM CODE FOR ALL KINDS OF PGM (POISSON, GAUSSIAN, AND MULTIPLICATIVE) MISCALCULATION. THERE ARE MANY SOURCES OF PGM ALARM. PGM ALARMS RESULT IN THE DESCRIBED ALARM ON THE DIALYSIS MACHINE. AS THIS TYPE OF PGM ALARM CAN BE CAUSED BY DIFFERENT CAUSES, THERE IS CURRENTLY NOT A SINGLE ROOT CAUSE. AN ALARM USUALLY LEADS TO THE TERMINATION OF THE TREATMENT AND TO THE STOP OF THE MACHINE. AFTER RESTART OF THE DEVICE, THE TREATMENT COULD BE CONTINUED. MANUAL BLOOD REINFUSION SHOULD ALWAYS BE POSSIBLE AND IS DESCRIBED IN INSTRUCTIONS FOR USE (IFU). THE SOFTWARE VERSION SOLVES SOME SOURCES WHICH LED TO THE ALARM. 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.
ADDITIONAL INFORMATION PROVIDED IN B5, D4, AND G2.
ADDITIONAL INFORMATION PROVIDED IN H10. INVESTIGATION: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY REVIEW (DHR) IS FOUND TO BE NOT NECESSARY 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 ALARM CODE IS A COLLECTIVE ALARM CODE FOR ALL KINDS OF PGM (POISSON, GAUSSIAN, AND MULTIPLICATIVE) MISCALCULATION. THERE ARE MANY SOURCES OF PGM ALARM. PGM ALARMS RESULT IN THE DESCRIBED ALARM ON THE DIALYSIS MACHINE. AS THIS TYPE OF PGM ALARM CAN BE CAUSED BY DIFFERENT CAUSES, THERE IS CURRENTLY NOT A SINGLE ROOT CAUSE. AN ALARM USUALLY LEADS TO THE TERMINATION OF THE TREATMENT AND TO THE STOP OF THE MACHINE. AFTER RESTART OF THE DEVICE, THE TREATMENT COULD BE CONTINUED. MANUAL BLOOD REINFUSION SHOULD ALWAYS BE POSSIBLE AND IS DESCRIBED IN INSTRUCTIONS FOR USE. THE SOFTWARE VERSION SOLVES SOME SOURCES WHICH LED TO THE ALARM. HOWEVER NOT ALL POSSIBLE SOURCES COULD BE/WERE ADDRESSED. THE SOURCES OF THOSE CASES WILL BE COLLECTED AND WILL BE CONSIDERED WITHIN THE SCOPE OF THE PRODUCT IMPROVEMENT PROCESS. IN THE CURRENT EVENT, THE DEVICE CRASHED DUE TO A SEGMENTATION FAULT, WHICH LEAD TO A SYSTEM EXCEPTION FORCING THE MACHINE TO ENTER A SAFE STATE. THE AVAILABLE TRACE DATA IS NOT ADEQUATE TO IDENTIFY THE ROOT COURSE. IT IS UNCLEAR WHY THE UNAUTHORIZED MEMORY ACCESS OCCURRED. FURTHER INVESTIGATIONS UNDER LABORATORY CONDITIONS WILL BE CARRIED OUT TO FIND OUT THE EXACT ROOT CAUSE OF THE SEGMENTATION ERROR. 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 PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT THE SCREEN WAS BLACK. THE TREATMENT COULD NOT BE CONTINUED. NO CONSEQUENCE TO THE PATIENT REPORTED. THE TREATMENT WAS CONTINUED WITH ANOTHER DEVICE. BLOOD LOSS WAS REPORTED AS LESS THAN 300ML. SAMPLE IS NOT AVAILABLE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT EXPERIENCED LESS THAN 300ML OF BLOOD LOSS. THE PATIENT COMPLETED TREATMENT AFTER RESTARTING ON ANOTHER DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER EVENT DETAILS PROVIDED.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT THE SCREEN WAS BLACK. THE TREATMENT COULD NOT BE CONTINUED. NO CONSEQUENCE TO THE PATIENT REPORTED. THE TREATMENT WAS CONTINUED WITH ANOTHER DEVICE. BLOOD LOSS WAS REPORTED AS LESS THAN 300ML. SAMPLE IS NOT AVAILABLE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT EXPERIENCED LESS THAN 300ML OF BLOOD LOSS. THE PATIENT COMPLETED TREATMENT AFTER RESTARTING ON ANOTHER DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER EVENT DETAILS PROVIDED.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT THE SCREEN WAS BLACK. THE TREATMENT COULD NOT BE CONTINUED. NO CONSEQUENCE TO THE PATIENT REPORTED. THE TREATMENT WAS CONTINUED WITH ANOTHER DEVICE. BLOOD LOSS WAS REPORTED AS LESS THAN 300ML. SAMPLE IS NOT AVAILABLE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT EXPERIENCED LESS THAN 300ML OF BLOOD LOSS. THE PATIENT COMPLETED TREATMENT AFTER RESTARTING ON ANOTHER DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER EVENT DETAILS PROVIDED.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT THE SCREEN WAS BLACK. THE TREATMENT COULD NOT BE CONTINUED. NO CONSEQUENCE TO THE PATIENT REPORTED. THE TREATMENT WAS CONTINUED WITH ANOTHER DEVICE. BLOOD LOSS WAS REPORTED AS LESS THAN 300ML. SAMPLE IS NOT AVAILABLE. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780709 | MULTIFILTRATE PRO MACHINE | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | SCHWEINFURT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |