CombiSet SMARTECH 03-2722-9CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840861102266), received between Jul 21, 2021 and Mar 20, 2026 — 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 16, 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.

• MalfunctionMar 20, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE HAD A LOOSE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER WINDOW AND THE RED ARTERIAL PORT CONNECTOR PIECE RESULTING IN BLOOD LOSS DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE ISSUE OCCURRED IMMEDIATELY AFTER THE INITIATION OF TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WERE NO CHANGES TO PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THERE WAS NO VISIBLE DAMAGE TO THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24650409 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT ON (B)(6) 2026 A FRESENIUS COMBISET BLOODLINE HAD A LOOSE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER WINDOW AND THE RED ARTERIAL PORT CONNECTOR PIECE RESULTING IN BLOOD LOSS DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE ISSUE OCCURRED IMMEDIATELY AFTER THE INITIATION OF TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WERE NO CHANGES TO PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THERE WAS NO VISIBLE DAMAGE TO THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24650363 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE HAD A LOOSE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER WINDOW AND THE RED ARTERIAL PORT CONNECTOR PIECE RESULTING IN BLOOD LOSS DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE ISSUE OCCURRED IMMEDIATELY AFTER THE INITIATION OF TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WERE NO CHANGES TO PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THERE WAS NO VISIBLE DAMAGE TO THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24650262 ↗
• MalfunctionOct 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CHARGE NURSE (CN) REPORTED A COMBISET BLOOD LEAK THAT OCCURRED WITHIN THE FIRST FEW MINUTES OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS OBSERVED LEAKING EXTERNALLY FROM THE VENOUS END OF THE DEVICE, DIRECTLY ABOVE THE ¿CLEAR HUB¿ WHERE THE NEEDLE CONNECTS TO THE TUBING. THE CN STATED THAT IT LOOKED LIKE THE TUBING WAS NOT FULLY SEALED (OR BONDED) TO THE CONNECTOR. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T HD MACHINE AND UTILIZING AN OPTIFLUX DIALYZER. THERE WERE NO MACHINE ALARMS. NO LEAKING WAS NOTICED DURING THE PRIMING PHASE. AS SOON AS THE LEAK WAS IDENTIFIED, THE TREATMENT WAS PAUSED. THE LINES WERE REVERSED AND THE PATIENT¿S BLOOD WAS RETURNED MANUALLY. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS REPORTEDLY LESS THAN 10 ML. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS OF THE DEFECT WERE ALSO UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572901 ↗
• MalfunctionJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY HEMODIALYSIS (HD) TECHNICIAN REPORTED BLOOD LEAKING FROM A FRESENIUS COMBISET DURING A PATIENT¿S TREATMENT. THE LEAK WAS COMING FROM THE ¿TOP OF THE ARTERIAL SIDE, THROUGH THE ROUND EDGES¿ OF THE INTEGRATED CLIC BLOOD CHAMBER. IT WAS REPORTED THAT A TINY SPOT OF DRIED BLOOD WAS NOTICED ON THE EXTERIOR OF THE TUBING SET APPROXIMATELY TWO HOURS INTO THE PATIENT¿S HD TREATMENT. THERE WAS NO VISIBLE DAMAGE NOTED ON THE DEVICE. THE DRIED BLOOD WAS FOUND JUST BELOW THE CONNECTION POINT ON THE TUBING SET. IT WAS SUSPECTED THAT THE CLIC BLOOD CHAMBER WAS NOT SEALED PROPERLY. BLOOD WAS NOT ACTIVELY LEAKING WHEN THIS WAS NOTICED. THE ESTIMATED BLOOD LESS WAS SAID TO BE LESS THAN 1 ML. THERE WERE NO MACHINE ALARMS DURING THE TREATMENT, AND NO OTHER ISSUES. THE PATIENT WAS ABLE TO CONTINUE AND COMPLETE THEIR TREATMENT WITH THE SAME SUPPLIES. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND UTILIZING A FRESENIUS OPTIFLUX DIALYZER. THE COMBISET WAS NOT AVAILABLE FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS WERE TAKEN OF THE SAMPLE AND PROVIDED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206229 ↗