CombiSet 03-2621-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840861100224), received between Jan 15, 2020 and Jan 29, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K962081); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S TECHNICAL MANAGER REPORTED THAT A COMBISET BLOODLINE LEAKED ABOUT THIRTY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21263702 ↗
• MalfunctionOct 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP. ABOUT AN HOUR INTO THE PATIENT¿S HD TREATMENT, THE HEPARIN LINE ¿BLEW OFF¿ (OR SEPARATED) AT THE RED ¿T¿ CONNECTION. THERE WERE NO MACHINE ALARMS. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T HD MACHINE AND UTILIZING AN ELISIO DIALYZER. THERE WERE NO VISIBLE DEFECTS NOTED ON THE BLOODLINE DURING THE PRE-TREATMENT INSPECTION. IT WAS ALSO CONFIRMED THAT THERE WAS NO LEAKING DURING THE PRIMING. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS REPORTEDLY 250 ML. IT WAS 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 REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571201 ↗
• MalfunctionOct 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP. IMMEDIATELY AFTER THE PATIENT WAS PUT ON THE MACHINE FOR HD TREATMENT, THE NURSE OBSERVED BLOOD DRIPPING FROM THE HEPARIN LINE RED ¿T¿ CONNECTION. THERE WERE NO MACHINE ALARMS. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T HD MACHINE AND UTILIZING AN ELISIO DIALYZER. THERE WERE NO VISIBLE DEFECTS NOTED ON THE BLOODLINE DURING THE PRE-TREATMENT INSPECTION. IT WAS ALSO CONFIRMED THAT THERE WAS NO LEAKING DURING THE PRIMING. THE PATIENT¿S BLOOD LOSS WAS MINIMAL; THEIR ESTIMATED BLOOD LOSS (EBL) WAS 2 ML. IT WAS 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 REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569870 ↗
• InjuryJan 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A HEMODIALYSIS (HD) OUTPATIENT CLINIC REPORTED THAT A BLOOD LEAK OCCURRED AN HOUR AND FIFTEEN MINUTES INTO A PATIENT¿S HD TREATMENT ON (B)(6) 2019. THE STAFF NOTICED BLOOD LEAKING FROM BEHIND THE PATIENT¿S CHAIR. THE LEAK WAS REPORTEDLY COMING FROM A HOLE IN THE VENOUS LINE OF THE COMBI SET. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 500 ML. AFTER THE BLOOD LEAK WAS DISCOVERED, THE TREATMENT WAS ENDED, THE BLOOD WAS CLEANED UP, AND THE PATIENT WAS TRANSFERRED TO A NEW MACHINE WITH STABLE VITAL SIGNS. AFTER COMPLETING TREATMENT ON THE NEW MACHINE, THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THE PATIENT AND THEIR SPOUSE WERE EDUCATED ON SIGNS OF ANEMIA AND INSTRUCTED TO GO TO THE EMERGENCY ROOM (ER) SHOULD ANY SIGNS/SYMPTOMS APPEAR. ON (B)(6) 2019 THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT WENT TO THE ER AND WAS PUT UNDER OBSERVATION. THE PATIENT¿S HEMOGLOBIN (HGB) ON ARRIVAL TO THE ER WAS 7.8 WHICH WAS A DROP FROM THE (B)(6) WHEN IT WAS 9.6. THE PATIENT RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS (PRBC) AND WAS DISCHARGED TO THEIR HOME ON (B)(6) 2019 WITH A HGB OF 8.7. THE PATIENT RETURNED TO THE HD CLINIC ON (B)(6) 2019 AND HAS BEEN CONTINUING TR

  Patient problems: Anemia; Chest Pain; Dyspnea; Weakness

  MAUDE report 9594306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962081. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2011 · Nov 19, 2010 · Terminated
  Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
• Z-0844-2011 · Nov 19, 2010 · Terminated
  Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7