HOME HEMO COMBI SET FOR CANADA
Received Jan 12, 2022 · Event occurred Dec 21, 2021
Report 8030665-2022-00043 · MDR key 13234183
Device
Generic name
Hemodialysis System For Home Use
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
03-2932-6
Lot number
20LR01003
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
66 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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
IT WAS REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING THE BLOOD RETURN PROCEDURE OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CLAMP ON THE SALINE LINE FAILED TO STAY CLOSED AND BLOOD REPORTEDLY BURST OUT. THERE WERE NO REPORTS OF ANY PATIENT HARM OR INJURY. THE PATIENT STATED THEY WOULD START USING BLOODLINES FROM A DIFFERENT LOT NUMBER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING THE BLOOD RETURN PROCEDURE OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CLAMP ON THE SALINE LINE FAILED TO STAY CLOSED AND BLOOD REPORTEDLY BURST OUT. THERE WERE NO REPORTS OF ANY PATIENT HARM OR INJURY. THE PATIENT STATED THEY WOULD START USING BLOODLINES FROM A DIFFERENT LOT NUMBER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.
Additional Manufacturer Narrative
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