MULTIFILTRATE PRO MACHINE
Report
- Report Number
- 0001225714-2024-00045
- Event Type
- Malfunction
- Date Received
- June 14, 2024
- Date of Event
- May 30, 2024
- Report Date
- July 10, 2024
- Manufacturer
- SCHWEINFURT
- Product Code
- KDI
- PMA / PMN Number
- EUA200149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION PROVIDED IN B3, B5 AND G2. PLANT INVESTIGATION: THE REVIEW OF THE COMPLAINTS REVEALED THAT THE REPORTED FAILURE TYPE REPRESENTS A KNOWN EVENT. INVESTIGATION OF MACHINES FILES REVEALED THAT A COMMUNICATION ERROR OCCURRED, WHICH ULTIMATELY RESULTED IN SYSTEM ERROR 9040.1. A REVIEW OF DEVICE HISTORY RECORD (DHR) WAS NOT COMPLETED 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 THE INSTRUCTIONS FOR USE (IFU). 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.
ADDITIONAL INFORMATION PROVIDED IN B5 AND D4.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
UPDATED INFORMATION WAS RECEIVED THAT CONFIRMED THE INITIAL REPORTED EVENT DETAILS WERE INCORRECT. THE UPDATED REPORTED EVENT DETAILS WERE CONFIRMED THAT DURING TREATMENT ON 05/30/2024, THE MACHINE STOPPED IN THE MIDDLE OF TREATMENT AT MIDNIGHT DUE TO AN INTERNAL DATA TRANSMISSION FAILURE. AS A RESULT, THE PATIENT EXPERIENCED AN UNKNOWN AMOUNT OF BLOOD LOSS BUT DID NOT EXPERIENCE HARM OR REQUIRE MEDICAL INTERVENTION. ADDITIONAL EVENT DETAILS HAVE BEEN REQUESTED BUT HAVE NOT BEEN OBTAINED.
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT EXPERIENCED 300ML OF BLOOD LOSS. NO FURTHER INFORMATION PROVIDED.
IT WAS REPORTED THAT DURING A PATIENT¿S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT THE HEALTHCARE PROFESSIONAL (HCP) ENTERED THE PATIENT'S ROOM TO ASSESS THEIR MACHINE. WHEN CYCLING THROUGH THE VARIOUS SCREENS ON MACHINE TO WRITE DOWN NUMBERS/PRESSURES, THE MACHINE STOPPED AND DISPLAYED AN ALARM THAT READ "INTERNAL ERROR". THE HCP ATTEMPTED TO TROUBLESHOOT THIS FOR APPROXIMATELY TWO MINUTES BEFORE THE PATIENT'S LINES WERE DOUBLE CLAMPED AND CALLED FOR HELP. A COLLEAGUE CAME TO ASSIST BUT BOTH WERE UNABLE TO TROUBLESHOOT THE ALARM. THE PATIENT'S LINES WERE CLAMPED TO PREVENT ANY FLOW OF CLOTTED BLOOD. OBSERVATIONS WERE COMPLETED AS SOON AS POSSIBLE (WITHIN A MINUTE OF DISCONNECTION FROM MACHINE) AND DOCTORS WERE CALLED BY THE CLINICAL STAFF PRESENT TO ASSESS. THE CONSULTANT ON CALL WAS PHONED AND INFORMED. THE CLINICAL TEAM REMOVED THE DEVICE FROM USE AND SENT IT TO THE MEDICAL DEVICE ENGINEERS TO PREVENT IT FROM BEING USED ON ANY OTHER PATIENTS. DUE TO THE EVENT, THE PATIENT WAS NOTED TO HAVE LOST APPROXIMATELY 300ML OF BLOOD. ADDITIONAL INFORMATION REQUESTED BUT HAS NOT BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368195 | MULTIFILTRATE PRO MACHINE | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | SCHWEINFURT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |