2008K@HOME HEMODIALYSIS SYSTEM
Received Apr 29, 2022 · Event occurred Apr 11, 2022
Report 0002937457-2022-00709 · MDR key 14251875
Device
Generic name
Hemodialysis System For Home Use
Manufacturer
Concord ManufacturingModel number
190828Catalog number
190828
Lot number
2K0S177626
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Dizziness
- Numbness
- Dizziness
- Numbness
Narrative
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS THAT THIS HOME HEMODIALYSIS PATIENT WAS IN TREATMENT UTILIZING THE 2008K@HOME HEMODIALYSIS MACHINE WHEN THEY BEGAN FEELING UNWELL. THE PATIENT COMPLAINED OF DIZZINESS AND NUMBNESS IN THE LEFT LEG. THE EVENT OCCURRED AT APPROXIMATELY 1514 HOURS (15 MINUTES AFTER THE START OF TREATMENT) AFTER THE PATIENT RECEIVED A HIGH VENOUS PRESSURE ALARM. THE PATIENT¿S BLOOD WAS RETURNED. THE PARAMEDICS WERE CALLED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. ADDITIONAL FOLLOW-UP YIELDED LIMITED INFORMATION RELATED TO THE EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TRANSITIONED TO IN-CENTER HEMODIALYSIS AND DISCONTINUED USE OF THE HOME HEMODIALYSIS MACHINE. NO ADDITIONAL DETAILS WERE AVAILABLE RELATED TO THE PATIENT¿S HOSPITAL COURSE OR DATE OF DISCHARGE. AN EVALUATION OF THE MACHINE ON 13/APR/2022 FOUND THE VENOUS AND ARTERIAL TRANSDUCER PRESSURES TO MEASURE AS EXPECTED WITH NO LEAKAGE OBSERVED. ADDITIONALLY, THE PRESSURE AND ALARM TESTS PASSED, AND THE ELECTRICAL SAFETY CHECK WAS CARRIED OUT SUCCESSFULLY. FURTHERMORE, THE BLOOD PRESSURE MODULE AND CUFFS WERE FOUND TO BE WORKING AS EXPECTED.
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE WAS EVALUATED (TECHNICIAN UNKNOWN) AND FOUND TO BE OPERATING AS EXPECTED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.