CombiSet 03-2622-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00840861100231), received between Jul 25, 2017 and Jul 31, 2025 — classified as 1 death, 193 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (191 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 25 most recent of 194 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY¿S SENIOR CLINICAL RISK ADVISOR REPORTED TO FRESENIUS MEDICAL CARE CANADA (FMCC) THAT A FRESENIUS COMBISET BLOODLINE CLOTTED ELEVEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22677816 ↗
• MalfunctionJul 31, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY¿S SENIOR CLINICAL RISK ADVISOR REPORTED TO FRESENIUS MEDICAL CARE CANADA (FMCC) THAT A FRESENIUS COMBISET BLOODLINE CLOTTED ELEVEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. IT IS UNKNOWN IF A FRESENIUS DIALYZER WAS IN USE. NO LOOSE CONNECTIONS WERE NOTED UPON INSPECTION. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE DURING TREATMENT. THE ORIGIN ON THE LEAK IS UNKNOWN. FOAM WAS NOTED IN THE VENOUS CHAMBER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 260ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT DID NOT RESUME TREATMENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22675009 ↗
• MalfunctionJul 30, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY REPORTED TO FRESENIUS MEDICAL CARE CANADA THAT A COMBI SET CLOTTED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT WHICH RESULTED IN AN UNKNOWN AMOUNT OF BLOOD LOSS. IT WAS REPORTED THAT AIR ALARMS WENT OFF APPROXIMATELY TEN MINUTES INTO THE TREATMENT. A SIGNIFICANT AMOUNT OF FOAM WAS OBSERVED POST-DIALYZER AND IN THE VENOUS CHAMBER. IT WAS IMPLIED THAT THE HEPARIN CAP ON THE COMBI SET WAS LOOSE, WHICH ALLOWED AIR TO ENTER THE CIRCUIT. THE COMBI SET CLOTTED BEFORE THE AIR COULD BE CLEARED FROM THE LINES, AND THE PATIENT ENDED UP LOSING THE ENTIRE CIRCUIT OF BLOOD. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22665043 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HD TREATMENT. THE MACHINE, A FRESENIUS 2008T SYSTEM, ALARMED WITH AN AIR DETECTOR MESSAGE APPROXIMATELY FIFTEEN MINUTES INTO THE TREATMENT. THE TECHNICIAN OPERATING THE MACHINE NOTICED AIR PRESENT IN THE DIALYZER AND LINES, AND SAW BLOOD DRIPPING FROM AN UNSPECIFIED LOCATION ON THE ARTERIAL LINE. THE FA CONFIRMED THERE WERE NO LINES THAT DISCONNECTED. THE TECHNICIAN STOPPED THE BLOOD PUMP AFTER OBSERVING THE LEAK, AND THE PATIENT WAS DISCONNECTED FROM THE SET UP. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE FA SAID THEY HAVE BEEN USING THE BLOODLINES WHICH REQUIRE THEM TO SCREW ON THE SALINE LINE, AND THE FA THINKS THE TECHNICIAN MAY HAVE MISTHREADED THE LINE CAUSING A LEAK AT THE CONNECTION POINT. CONVERSELY, THE TECHNICIAN BELIEVES THERE WAS A HOLE IN THE ARTERIAL LINE. THE FA DID NOT SEE ANY VISIBLE DAMAGE ON THE LINE AND COULD NOT CORROBORATE THE ALLEGATION OF A HOLE. THERE WERE NO LEAKS DURING THE PRIME, AND THERE WERE NO KNOWN CHANGES IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE FA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21552807 ↗
• MalfunctionFeb 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY PATIENT CARE TECHNICIAN (PCT) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE FACILITY¿S CLINICAL MANAGER (CM). THE BLOOD LEAK, WHICH WAS CAUSED BY A SEPARATION, OCCURRED APPROXIMATELY TWO HOURS AND THIRTY MINUTES INTO THE TREATMENT. IT WAS REPORTED THAT A VENOUS PRESSURE ALARM HAD OCCURRED. THE PCT TRIED TO LOWER THE PRESSURE BY RELEASING THE VENOUS CLAMP, BUT THE SALINE LINE SEPARATED AT THE T-CONNECTION. THE BLOOD PUMP WAS STILL ON WHEN THIS HAPPENED, WHICH ALLOWED AIR TO ENTER THE SYSTEM. ONCE THE LEAK WAS IDENTIFIED, THE LINES WERE CLAMPED, AND THE PATIENT WAS DISCONNECTED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 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 NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND NO PHOTOS OF THE DEVICE WERE AVAILABLE FOR REVIEW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21499112 ↗
• MalfunctionJan 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S RISK MANAGER REPORTED THAT A BLOODLINE LEAKED FROM THE BLOOD PUMP SEGMENT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 200ML. 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.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21218231 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE RN. THE BLOOD LEAK OCCURRED AT THE VERY BEGINNING OF TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED WITH AN AIR DETECTOR ALARM. THE STAFF NOTICED BLOOD LEAKING FROM THE TUBING IN THE BLOOD PUMP. THERE WERE NO LEAKS DURING THE PRIMING PHASE. THE PATIENT¿S BLOOD WAS UNABLE TO BE RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 400 ML. THE MACHINE WAS RE-SETUP WITH NEW SUPPLIES SO THE PATIENT COULD CONTINUE THEIR TREATMENT. WHEN THE BLOODLINE TUBING WAS REMOVED FROM THE MACHINE, A NICK WAS FOUND ON THE TUBING IN THE SAME AREA WHERE THE LEAK WAS COMING FROM. AFTER RESTARTING WITH NEW SUPPLIES, THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT WITHOUT FURTHER INCIDENT. THE RN 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 SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20870744 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE RN. THE BLOOD LEAK OCCURRED ABOUT TWO HOURS INTO THE PATIENT¿S TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED WITH AN AIR DETECTOR ALARM. THE STAFF NOTICED BLOOD LEAKING FROM THE TUBING IN THE BLOOD PUMP. THERE WERE NO LEAKS DURING THE PRIMING PHASE. THE PATIENT¿S BLOOD WAS ABLE TO BE RETURNED FROM THE ARTERIAL SIDE ONLY. THEIR ESTIMATED BLOOD LOSS (EBL) WAS 250 ML. THE MACHINE WAS RE-SETUP WITH NEW SUPPLIES SO THE PATIENT COULD CONTINUE THEIR TREATMENT. WHEN THE BLOODLINE TUBING WAS REMOVED FROM THE MACHINE, A NICK WAS FOUND ON THE TUBING IN THE SAME AREA WHERE THE LEAK WAS COMING FROM. AFTER RESTARTING WITH NEW SUPPLIES, THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT WITHOUT FURTHER INCIDENT. THE RN 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 SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20870507 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO CUSTOMER SERVICE THAT A COMBI SET¿S HEPARIN LINE DISCONNECTED FROM THE BLOOD PUMP SEGMENT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE COMPLAINT DEVICE IS NOT 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 19794865 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO CUSTOMER SERVICE THAT A COMBI SET¿S HEPARIN LINE DISCONNECTED FROM THE BLOOD PUMP SEGMENT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE COMPLAINT DEVICE IS NOT 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 19793893 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO CUSTOMER SERVICE THAT A COMBI SET¿S HEPARIN LINE DISCONNECTED FROM THE BLOOD PUMP SEGMENT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE COMPLAINT DEVICE IS NOT 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 19793803 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO CUSTOMER SERVICE THAT A COMBI SET'S HEPARIN LINE DISCONNECTED FROM THE BLOOD PUMP SEGMENT DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE COMPLAINT DEVICE IS NOT 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 19793731 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO CUSTOMER SERVICE THAT A COMBI SET¿S HEPARIN LINE DISCONNECTED FROM THE BLOOD PUMP SEGMENT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THE COMPLAINT DEVICE IS NOT 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 19793641 ↗
• MalfunctionMar 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY PHYSICIAN REPORTED TO FRESENIUS THAT A BROKEN LINE WAS DETECTED ON THE COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REPORTED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. NO PARTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18888559 ↗
• MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A LINE OCCLUDED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. IT DID NOT ALLOW LIQUID TO FLOW AT THE JUNCTION OF THE SEGMENT AND HEPARIN LINE. THE STAFF IMMEDIATELY REPLACED THE PRODUCT WITH THE NEW SUPPLIES. UPON FOLLOW-UP, THE FACILITY REPORTED THE CUSTOMER CONFIRMED THAT THE BLOOD LINE DID NOT PRESENT WITH AN OCCLUSION, AND A BLOOD LEAK WAS OBSERVED ONE MINUTE BEFORE ENDING THE PATIENT¿S HEMODIALYSIS (HD) SESSION. THERE WAS NO DAMAGE WAS NOTED ON THE COMIBSET. THE MACHINE, A FRESENIUS 4008S V10 CLASICA, DID NOT ALARM AS THE BLOOD LEAK WAS EXTERNAL. THE EXACT LOCATION OF THE LEAK WAS NOT SPECIFIED. IT WAS UNKNOWN IF A FRESENIUS DIALYZER WAS BEING USED AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOST, AND THE CUSTOMER STATED THAT THEY ONLY WANTED TO REPORT THAT THE HEPARIN LINE WAS OCCLUDED. IT WAS REPORTED DUE TO THE EXTERNAL LEAK OCCURRING AT THE END OF THE TREATMENT, IT WAS NOT NECESSARY TO CHANGE THE SUPPLIES, AND THE PATIENT CONCLUDED THE TREATMENT WITH THE SAME SUPPLIES. THE ESTIMATED BLOOD LOSS (EBL) TO THE PATIENT WAS 2ML. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18347934 ↗
• MalfunctionDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A LINE OCCLUDED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. IT DID NOT ALLOW LIQUID TO FLOW AT THE JUNCTION OF THE SEGMENT AND HEPARIN LINE. THE STAFF IMMEDIATELY REPLACED THE PRODUCT WITH THE NEW SUPPLIES. UPON FOLLOW-UP, THE FACILITY REPORTED THE OCCLUSION WAS OBSERVED IMMEDIATELY UPON STARTING TREATMENT. THERE WERE NO BLOOD CLOTS OR BLOOD LEAKS WERE OBSERVED WITHIN THE LINES OR DIALYZER, AND NO DAMAGE WAS NOTED ON THE COMIBSET. THE CAUSE OF THE OCCLUSION WAS UNKNOWN. THE MACHINE, A FRESENIUS 4008S V10 CLASIC, DID NOT ALARM. A FRESENIUS DIALYZER WAS BEING USED AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOST, AND THE CUSTOMER STATED THAT THEY ONLY WANTED TO REPORT THAT THE HEPARIN LINE WAS OCCLUDED. THE TREATMENT WAS NOT STOPPED, AND THE PATIENT CONTINUED TREATMENT ON THE SAME MACHINE WHERE THEY WERE ABLE TO COMPLETE TREATMENT. NO SUPPLIES WERE CHANGED. THERE WAS NO ESTIMATED BLOOD LOSS (EBL) TO THE PATIENT. 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 SAMPLE WAS DISCARDED WAS NO LONGER AVAILABLE TO BE RETU

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18347908 ↗
• MalfunctionNov 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MEDICAL DIRECTOR REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT WITH THE COMBISET BLOODLINES. THE HEPARIN LINE DETACHED FROM THE BLOODLINE SET. THE BLOODLINES WERE REPLACED TO RESOLVE THE REPORTED ISSUE AND COMPLETE TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE REPORTED ISSUE OCCURRED APPROXIMATELY AN HOUR AND A HALF INTO TREATMENT. NO ALARMS WERE RECEIVED FROM THE MACHINE (MODEL UNKNOWN). IT WAS NOT STATED WHETHER THERE WAS A CHANGE OR DISRUPTION IN PRESSURE THAT WOULD HAVE CAUSED THE REPORTED ISSUE OR TRIGGERED THE MACHINE TO ALARM. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 50 ML. THE BLOODLINES WERE REPLACED AND TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH THE SAME DIALYZER. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18185551 ↗
• MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY TECHNICAL ASSISTANT REPORTED DURING HEMODIALYSIS (HD) TREATMENT, AN EXTERNAL LEAKAGE WAS NOTED THROUGH THE HEPARIN LINE. THE STAFF IMMEDIATELY REPLACED THE DEFECTIVE PIECE WITH NEW SUPPLIES IN ORDER TO FINISH THE TREATMENT. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT AS REPORT AT INTAKE. UPON FOLLOW-UP RECEIVED, IT WAS REPORTED THE BLOOD LEAK OCCURRED TEN MINUTES AFTER INITIATION OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. IT WAS REPORTED THE HEPARIN LINE DETACHED AND CAUSED THE BLOOD LEAK. THE UNKNOWN HD MACHINE DID NOT ALARM WITH A BLOOD LEAK ALARM AND BLOOD LEAK TEST STRIPS WERE NOT USED. NO DAMAGE AND/OR DEFECTS WERE NOTED. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH THE BLOODLINE REPLACED. THE ESTIMATED BLOOD LOSS (EBL) WAS 10ML. IT WAS UNKNOWN IF THE PATIENT'S BLOOD WAS RETURNED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18117651 ↗
• MalfunctionOct 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MEDICAL DIRECTOR REPORTED TO FRESENIUS THAT A LEAK OCCURRED AT THE HEPARIN LINE OF THE COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE OCCURRED WITHIN TWO MINUTES OF TREATMENT INITIATION ON A FRESENIUS 4008S MACHINE. IT WAS NOT REPORTED THAT ANY DEFECT OR DAMAGE WAS NOTED TO THE BLOODLINES. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 1 ML. TREATMENT WAS RESTARTED ON THE SAME MACHINE AND SUCCESSFULLY COMPLETED WITH NEW SUPPLIES. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18041228 ↗
• MalfunctionOct 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MEDICAL DIRECTOR REPORTED TO FRESENIUS THAT A LEAK OCCURRED AT THE HEPARIN LINE OF THE COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE REPORTED ISSUE OCCURRED WITHIN THREE MINUTES OF TREATMENT INITIATION ON A FRESENIUS 4008S MACHINE. IT WAS NOT REPORTED THAT ANY DEFECT OR DAMAGE WAS NOTED TO THE BLOODLINES. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 ML. TREATMENT WAS RESTARTED ON THE SAME MACHINE AND SUCCESSFULLY COMPLETED WITH NEW SUPPLIES. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR "PHYSICAL" EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18041093 ↗
• MalfunctionSep 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A COMBI SET BLOOD LEAK THAT OCCURRED UPON THE START OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS REPORTED THAT THE COMBI SET HAD A MANUFACTURING DEFECT ON THE TRANSDUCER OF THE ARTERIAL LINE. THE TRANSDUCER WAS REPORTED TO BE ILL FITTING AND HAD A CRACK WHICH CAUSED AIR TO ENTER THE CIRCUIT. HOWEVER, UPON FOLLOW-UP IT COULD NOT BE CONFIRMED IF THERE WAS A VISIBLE CRACK ON THE TRANSDUCER. IT WAS CONFIRMED THAT THERE WERE NO LEAKS DURING THE PRIMING PHASE. IT WAS ALSO CONFIRMED THAT THE DEVICE WAS NOT DROPPED PRIOR TO USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS 200 ML. THE MACHINE, A 4008S, DID NOT PRODUCE ANY ALARMS. 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 COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17834671 ↗
• MalfunctionApr 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A CRACK WAS IDENTIFIED IN THE VENOUS CHAMBER OF THE COMBISET BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THERE WAS BLOOD LOSS AS A RESULT OF THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. THERE WAS NO ADVERSE EVENT OR REQUIRED MEDICAL INTERVENTION REPORTED. THE PATIENT CONTINUED TREATMENT AFTER THE BLOODLINES WERE REPLACED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702043 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A COMIBI SET HAD CRACKED TUBING WHICH REPORTED IN BLOOD LEAKING DURING A HEMODIALYSIS (HD) PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486192 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A COMIBI SET HAD CRACKED TUBING WHICH REPORTED IN BLOOD LEAKING DURING A HEMODIALYSIS (HD) PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486191 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED A COMIBI SET HAD CRACKED TUBING WHICH REPORTED IN BLOOD LEAKING DURING A HEMODIALYSIS (HD) PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486187 ↗

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