2008K@HOME MACHINE
Received Apr 30, 2021 · Event occurred Jan 1, 2021
Report 2937457-2021-00907 · MDR key 11753261
Device
Generic name
Hemodialysis System For Home Use
Manufacturer
Concord ManufacturingCatalog number
UNKNOWN-2008K@HOME MACHINE
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G1 PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE SERIAL NUMBER COULD NOT BE OBTAINED. AS A SERIAL NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
A PATIENT REPORTED THAT AN ALARM WOULD OCCUR "AT TIMES" ON A HOME HEMODIALYSIS (HD) MACHINE, AND THE MACHINE WOULD SHUT OFF TOWARDS THE END OF TREATMENT CAUSING BLOOD LOSS. THE PATIENT STATED THE BLOOD WOULD DRY WHILE THEY TRIED TO FIGURE OUT THE ALARM PROBLEM. ADDITIONAL INFORMATION WAS NOT PROVIDED.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A PATIENT REPORTED THAT AN ALARM WOULD OCCUR "AT TIMES" ON A HOME HEMODIALYSIS (HD) MACHINE, AND THE MACHINE WOULD SHUT OFF TOWARDS THE END OF TREATMENT CAUSING BLOOD LOSS. THE PATIENT STATED THE BLOOD WOULD DRY WHILE THEY TRIED TO FIGURE OUT THE ALARM PROBLEM. ADDITIONAL INFORMATION WAS NOT PROVIDED.