CombiSet 03-2692-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840861100262), received between May 29, 2018 and Jan 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT THE ARTERIAL CHAMBER ON THE BLOODLINE SET FILLED WITHOUT OPENING THE CLAMP AND THE HEPARIN LINE OCCLUDED AND PREVENTED THE PASSAGE OF SOLUTION DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE SUPPLIES. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. TREATMENT WAS PERFORMED ON A 4008S MACHINE. IT WAS NOT REPORTED HOW FAR INTO TREATMENT THE FAILURE OCCURRED. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50 ML. TREATMENT WAS RESTARTED ON THE SAME MACHINE AND COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. NO LOOSE CONNECTIONS WERE IDENTIFIED. NO DEFECT OR DAMAGE WAS NOTED. THE SAMPLE WAS NOT REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18588999 ↗
• MalfunctionJan 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT THE ARTERIAL CHAMBER ON THE BLOODLINE SET FILLED WITHOUT OPENING THE CLAMP AND THE HEPARIN LINE OCCLUDED AND PREVENTED THE PASSAGE OF SOLUTION DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE WAS RESOLVED BY REPLACING THE SUPPLIES. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. TREATMENT WAS PERFORMED ON A 4008S MACHINE. IT WAS NOT REPORTED HOW FAR INTO TREATMENT THE FAILURE OCCURRED. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50 ML. TREATMENT WAS RESTARTED ON THE SAME MACHINE AND COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. NO LOOSE CONNECTIONS WERE IDENTIFIED. NO DEFECT OR DAMAGE WAS NOTED. THE SAMPLE WAS NOT REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18588972 ↗
• MalfunctionJun 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT THE LOW VOLUME PRE-PUMP BLOODLINES WERE USED FOR TREATMENT WITH A FRESENIUS 2008 HEMODIALYSIS (HD) MACHINE WHEN THE VENOUS CHAMBER FILLED WITH BLOOD AND THEY "TRIED TO REMOVE IT BUT WERE UNSUCCESSFUL." ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. IT WAS NOT STATED DURING INITIAL REPORTING THAT THE PATIENT EXPERIENCED A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654455 ↗
• MalfunctionJun 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT THE LOW VOLUME PRE-PUMP BLOODLINES WERE USED FOR TREATMENT WITH A FRESENIUS 2008 HEMODIALYSIS (HD) MACHINE WHEN THE VENOUS CHAMBER FILLED WITH BLOOD AND THEY "TRIED TO REMOVE IT BUT WERE UNSUCCESSFUL." ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. IT WAS NOT STATED DURING INITIAL REPORTING THAT THE PATIENT EXPERIENCED A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654425 ↗
• MalfunctionMay 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A NURSE MANAGER AT A USER FACILITY REPORTED THAT THE HEPARIN LINE WAS OBSTRUCTED AND THAT DURING TREATMENT THE HEPARIN IS UNABLE TO BE INFUSED. CONSEQUENTLY, PATIENT¿S BLOOD ENDED UP CLOTTING WITHIN FIVE MINUTES REMAINING IN TREATMENT. PATIENT¿S ESTIMATED BLOOD LOSS WAS APPROXIMATELY 200 ML. THE MACHINE, A FRESENIUS 2008K2 MACHINE, DID ALARM APPROPRIATELY WITH HEPARIN PUMP ALARM. ADDITIONALLY, THE NURSE MANAGER REPORTED THAT TREATMENT WAS NO COMPLETED; HOWEVER, REPORTED THAT THE PATIENT HAS BEEN ABLE TO COMPLETE REGULARLY SCHEDULE HEMODIALYSIS (HD) TREATMENTS SINCE THE EVENT. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548366 ↗