MULTIFILTRATE PRO MACHINE
Report
- Report Number
- 0001225714-2024-00050
- Event Type
- Malfunction
- Date Received
- July 22, 2024
- Date of Event
- July 8, 2024
- Report Date
- August 9, 2024
- Manufacturer
- SCHWEINFURT
- Product Code
- KDI
- PMA / PMN Number
- EUA200149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
INVESTIGATION: THE REVIEW OF THE COMPLAINTS REVEALED THAT THE REPORTED FAILURE TYPE REPRESENTS A KNOWN EVENT. A COMMUNICATION ERROR OCCURRED, WHICH ULTIMATELY RESULTED IN SYSTEM ERROR 9040.1. AT PRESENT, THERE IS NO SOFTWARE THAT CAN BE USED TO CORRECT THIS ERROR BEHAVIOR. THE ERROR IS BEING INVESTIGATED. AFTER SWITCHING THE SYSTEM OFF AND ON, IT SHOULD WORK AGAIN. AN UPDATE TO SOFTWARE VERSION IS HOWEVER RECOMMENDED TO MITIGATE THE RISK FOR FALSE POSITIVE T1-TESTS AFTER INITIAL T1-TEST HAS FAILED. A REVIEW OF THE DEVICE HISTORY RECORD (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 9040.1 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 9040.1 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. A 9040.1 ALARM 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. 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 DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT A 9048.1 SYSTEM ERROR OCCURRED ONE HOUR INTO TREATMENT. IT WAS NOTED THAT THE CAUSE OR ORIGIN IS UNCLEAR, HOWEVER, MIGHT HAVE BEEN CAUSED BY HL7 CORRECTION. THE MACHINE WAS LOCALIZED IN THE ICU. DUE TO THE EVENT, THE PATIENT WAS NOTED TO HAVE LOST APPROXIMATELY 500ML OF BLOOD. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT A 9048.1 SYSTEM ERROR OCCURRED ONE HOUR INTO TREATMENT. IT WAS NOTED THAT THE CAUSE OR ORIGIN IS UNCLEAR, HOWEVER, MIGHT HAVE BEEN CAUSED BY HL7 CORRECTION. THE MACHINE WAS LOCALIZED IN THE ICU. DUE TO THE EVENT, THE PATIENT WAS NOTED TO HAVE LOST APPROXIMATELY 500ML OF BLOOD. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT A 9048.1 SYSTEM ERROR OCCURRED ONE HOUR INTO TREATMENT. IT WAS NOTED THAT THE CAUSE OR ORIGIN IS UNCLEAR, HOWEVER, MIGHT HAVE BEEN CAUSED BY HL7 CORRECTION. THE MACHINE WAS LOCALIZED IN THE ICU. DUE TO THE EVENT, THE PATIENT WAS NOTED TO HAVE LOST APPROXIMATELY 500ML OF BLOOD. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2221234 | MULTIFILTRATE PRO MACHINE | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | SCHWEINFURT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |