CombiSet 03-2742-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00840861100309), received between Jun 29, 2017 and Feb 28, 2025 — classified as 2 deaths, 7 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (79 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. 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A BLOODLINE LEAKED IMMEDIATELY AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED DUE TO A SEPARATION BETWEEN THE MEDICATION ADMINISTRATION LINE AND THE VENOUS CHAMBER. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON THE SAME MACHINE WITH A NEW BLOODLINE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21493830 ↗
• MalfunctionFeb 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CLINIC MANAGER (CM) FOR A USER FACILITY REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH A CUSTOM COMBISET BLOODLINE SET UPON INITIATING THIS PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOODLINE SET WAS TESTED AND PRIMED WITHOUT ISSUE. THE PATIENT WAS THEN CONNECTED FOR TREATMENT TO A FRESENIUS 2008T MACHINE WITH A FRESENIUS DIALYZER. THE BLOOD LEAK OCCURRED AS THE BLOOD FLOW RATE (BFR) WAS INCREASED. NO MACHINE ALARMS WERE RECEIVED. THE PATIENT CARE TECHNICIAN (PCT) HAD VISUALLY OBSERVED BLOOD ¿SHOOTING¿ FROM THE ARTERIAL LINE. THE CM INDICATED THAT HOLES WERE FOUND IN THE TUBING APPROXIMATELY 12 INCHES DOWN FROM THE CATHETER CONNECTION. TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) FOR THIS TREATMENT WAS 500 ML. THERE WERE NO SERIOUS INJURIES OR REQUIRED MEDICAL INTERVENTION THAT RESULTED FROM THESE ISSUES. TREATMENT WAS RESTARTED AND COMPLETED ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21292645 ↗
• MalfunctionNov 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A CUSTOM COMBI SET'S ARTERIAL LINE SEPARATED AT THE BOTTOM OF THE "T" FIVE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN ¿AIR IN LINE¿ ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20588494 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT AN CUSTOM COMBI SET BLOODLINE SEPARATED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. 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. A PHOTO HAS BEEN PROVIDED. 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 20533521 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S PROGRAM MANAGER REPORTED THAT A CUSTOMER COMBI SET DISCONNECTED 20 SECONDS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE DISCONNECTION OCCURRED AT THE ¿T¿ CONNECTION. THE MACHINE, A FRESENIUS 2008T HEMODIALYSIS MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE DISCARDED, BUT A PHOTO HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20215613 ↗
• MalfunctionSep 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A COMBISET BLOODLINE SEPARATED 2 HOURS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. THE SEPARATION OCCURRED WHERE THE ARTERIAL LINE CONNECTS TO THE DIALYZER. THERE WAS NO DAMAGE NOTICED ON EITHER THE BLOODLINE OR THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20200326 ↗
• MalfunctionAug 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. BLOOD WAS NOTED TO BE LEAKING ONTO THE PATIENT¿S CLOTHING. AFTER TROUBLESHOOTING THE SOURCE OF THE LEAK, A CRACK WAS NOTED ON THE ¿CONNECTING HUB¿ OF THE COMBI SET. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH A REGISTERED NURSE (RN) FROM THE FACILITY. THE RN CONFIRMED THAT BLOOD WAS LEAKING OUT OF THE CONNECTING HUB AT THE END OF THE VENOUS LINE, WHERE IT CONNECTS TO THE NEEDLE. THE RN INDICATED THAT THE TREATMENT HAD STARTED LESS THAN THIRTY MINUTES PRIOR TO IDENTIFYING THE LEAK. THERE WERE NO MACHINE ALARMS THAT OCCURRED, AND NO LEAKS WERE NOTICED DURING THE PRIME. THERE WERE NO OBVIOUS SIGNS OF ANY DEFECTS ON THE COMBI SET WHEN THE CIRCUIT WAS INITIALLY SET UP. HOWEVER, UPON CLOSE INSPECTION OF THE DEVICE AFTER THE LEAK OCCURRED, A CRACK WAS OBSERVED ON THE CONNECTOR. THE CRACK WAS CONFIRMED TO BE LOCATED ON A COMPONENT OF THE COMBI SET. THE TREATMENT WAS IMMEDIATELY HALTED ONCE THE LEAK WAS IDENTIFIED. BLOOD WAS RETURNED FROM THE ARTERIAL SIDE OF THE SET UP ONLY. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 150 ML. THE RN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19899169 ↗
• MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH THE COMBISET TRUEFLOW SERIES BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) (NOT A FRESENIUS PRODUCT) AND THE BLOODLINES. THE CONNECTION WAS NOT THREADING AND SECURING PROPERLY. BLOOD WAS LEAKING FROM CONNECTION AND THE CONNECTION WAS "TIGHTENED AGGRESSIVELY" TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 ML. UPON TIGHTENING THE CONNECTION, TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH THE SAME SUPPLIES. 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 18955528 ↗
• MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH THE COMBISET TRUEFLOW SERIES BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) (NOT A FRESENIUS PRODUCT) AND THE BLOODLINES. THE CONNECTION WAS NOT THREADING AND SECURING PROPERLY. BLOOD WAS LEAKING FROM CONNECTION AND THE CONNECTION WAS "TIGHTENED AGGRESSIVELY" TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 ML. UPON TIGHTENING THE CONNECTION, TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH THE SAME SUPPLIES. 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 18955527 ↗
• MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH THE COMBISET TRUEFLOW SERIES BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) (NOT A FRESENIUS PRODUCT) AND THE BLOODLINES. THE CONNECTION WAS NOT THREADING AND SECURING PROPERLY. BLOOD WAS LEAKING FROM CONNECTION AND THE CONNECTION WAS "TIGHTENED AGGRESSIVELY" TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 ML. UPON TIGHTENING THE CONNECTION, TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH THE SAME SUPPLIES. 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 18955526 ↗
• MalfunctionMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH THE COMBISET TRUEFLOW SERIES BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) (NOT A FRESENIUS PRODUCT) AND THE BLOODLINES. THE CONNECTION WAS NOT THREADING AND SECURING PROPERLY. BLOOD WAS LEAKING FROM CONNECTION AND THE CONNECTION WAS "TIGHTENED AGGRESSIVELY" TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION REGARDING THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10 ML. UPON TIGHTENING THE CONNECTION, TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH THE SAME SUPPLIES. 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 18955525 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY FACILITY ADMINISTRATOR (FA) REPORTED A BLOOD LEAK AT THE ARTERIAL LINE FROM THE RED CONNECTOR AT THE RIGHT SIDE OF THE BLOOD PUMP DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. THE SAMPLE WAS REPORTEDLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18896345 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY ADMINISTRATOR (FA) REPORTED A BLOOD LEAK AT THE ARTERIAL LINE FROM THE RED CONNECTOR AT THE RIGHT SIDE OF THE BLOOD PUMP DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE FA STATED A COMBI SET BLOOD LEAK OCCURRED ON THE ARTERIAL LINE ON THE RED CONNECTION RIGHT SIDE OF THE PUMP SEVERAL SECONDS AFTER INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE DID NOT ALARM WITH A BLOOD LEAK ALERT. A FRESENIUS 2008T MACHINE AND FRESENIUS DIALYZER WERE BEING UTILIZED FOR THE TREATMENT. NO VISIBLE DAMAGE WAS IDENTIFIED ON THE COMBI SET PRIOR TO USE. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS PLACED ON A DIFFERENT MACHINE AND A NEW DIALYZER AND COMBI SET WERE RE-STRUNG, AND THE PATIENT BEGAN COMPLETED TREATMENT WITHOUT FURTHER ISSUE. THE MACHINE WAS SERVICED AND PLACED BACK IN SERVICE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. 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 BMT STATED THE USED COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18896343 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY FACILITY ADMINISTRATOR (FA) REPORTED A BLOOD LEAK AT THE ARTERIAL LINE FROM THE RED CONNECTOR AT THE RIGHT SIDE OF THE BLOOD PUMP DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. THE SAMPLE WAS REPORTEDLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18896334 ↗
• MalfunctionJan 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT THE INJECTION PORT ON THE SALINE LINE OF THE COMBISET BLOODLINES LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN AIR IN THE CIRCUIT. THE PATIENT'S BLOOD WAS NOT RETURNED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CM AND A USER FACILITY REGISTERED NURSE (RN). THE RN STATED THE REPORTED ISSUE OCCURRED APPROXIMATELY 30-45 DAYS PRIOR TO INITIAL REPORTING. THE RN STATED THAT WITHIN THE FIRST HOUR OF TREATMENT THAT BLOOD WAS VISUALLY OBSERVED DRIPPING. THE 2008T MACHINE ALARMED WITH AN AIR DETECTOR MESSAGE. THE RN STATED THAT AIR WAS SUCKED INTO THE INJECTION AND BACKFLOWING OUT OF SALINE LINE. THE RN STATED THAT THE ARTERIAL SIDE HAD FILLED WITH AIR. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE BLOODLINE SET WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18527497 ↗
• MalfunctionJan 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT THE INJECTION PORT ON THE SALINE LINE OF THE COMBISET BLOODLINES LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN AIR IN THE CIRCUIT. THE PATIENT'S BLOOD WAS NOT RETURNED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CM AND A USER FACILITY REGISTERED NURSE (RN). THE REPORTED ISSUE WAS DETECTED APPROXIMATELY 1H45 MINUTES AFTER TREATMENT INITIATION. THE SALINE LINE WAS FOUND TO BE DRIPPING. THE 2008T MACHINE ALARMED WITH AN AIR DETECTOR MESSAGE. THE RN STATED THE ENTIRE CIRCUIT HAD FILLED WITH AIR. THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE WITH NEW SUPPLIES. THE BLOODLINE SET WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18527138 ↗
• MalfunctionJan 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A FLUID LEAK OCCURRED WITH THE COMBISET BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE LINE THAT CONNECTS TO THE VENOUS SIDE OF THE FRESENIUS DIALYZER DISENGAGED FROM THE BLUE THREADED CONNECTION. THE ISSUE OCCURRED UPON TREATMENT INITIATION. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE CM. THERE WAS NO DEFECT OR DAMAGE NOTED TO THE BLOODLINES. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 100 ML. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Blood Protein Abnormal; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18519975 ↗
• MalfunctionDec 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT TOWARDS THE END OF TREATMENT THE VENOUS CHAMBER OF THE COMBISET BLOODLINE SET 100% FILLED UP AND A CERTIFIED CLINICAL HEMODIALYSIS TECHNICIAN (CCHT) NOTICED BLOOD DRIPPING FROM A SMALL HOLE ON THE TOP PART OF THE VENOUS CHAMBER. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE REPORTED ISSUE OCCURRED APPROXIMATELY AN HOUR PRIOR TO TREATMENT COMPLETION. THE VENOUS CHAMBER FILLED WITH BLOOD AND A BLOOD LEAK WAS VISUALLY OBSERVED THAT ORIGINATED FROM A HOLE IN THE BLOODLINE SET. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 100 ML. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18384045 ↗
• MalfunctionNov 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED BLOOD WAS NOTED COMING FROM THE BLOOD PUMP SEGMENT OF THE BLOODLINE. AFTER INSPECTING THE BLOODLINE AFTER IT WAS REMOVED FROM THE MACHINE, IT WAS NOTED THAT A SMALL SLIT WAS ALONG SIDE OF THE INSIDE OF THE LINE. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18056278 ↗
• MalfunctionJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS VIA VOLUNTARY MEDWATCH REPORT MDR# MW5118139 THAT THE SALINE LINE DISCONNECTED FROM THE FRESENIUS COMBISET BLOODLINES DURING A PATIENT'S HEMODIALYSIS TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE PATIENT CARE TECHNICIAN (PCT). THE NURSE WAS HANDLING THE COMBISET LINES AND PREPARING TO ADMINISTER MEDICATION TO THE PATIENT WHEN THE SALINE LINE DISCONNECTED. TREATMENT WAS PAUSED AND THE LINES WERE IMMEDIATELY CLAMPED. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 CC. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT SAMPLE WAS REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17200303 ↗
• MalfunctionJun 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A COMBI SET BLOODLINE SEPARATION OCCURRED AT THE BEGINNING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT WHICH RESULTED IN BLOOD LOSS. ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP WITH A REGISTERED NURSE (RN) FAMILIAR WITH THE EVENT. THE RN CONFIRMED THAT A BLOODLINE SEPARATION HAD OCCURRED APPROXIMATELY FIFTEEN TO TWENTY MINUTES INTO A PATIENT'S HD TREATMENT. A PATIENT CARE TECHNICIAN (PCT) NOTICED A PUDDLE OF BLOOD ON THE FLOOR NEXT TO THE HD MACHINE. THE PCT SAW THAT THE NORMAL SALINE (NS) LINE HAD COMPLETELY DETACHED AT THE T-LINE SEGMENT OF THE ARTERIAL LINE GOING TO THE ARTERIAL CHAMBER. THE PCT IMMEDIATELY CLAMPED THE ARTERIAL AND VENOUS LINES AND STOPPED THE BLOOD PUMP. THE PATIENT'S BLOOD WAS NOT RETURNED. NO ABNORMALITIES WERE NOTED LEADING UP TO THE EVENT, AND THERE WERE NO REPORTED PRESSURE CHANGES OR ANY CHANGES TO THE BLOOD FLOW RATE (BFR). THE RN ALSO STATED THERE WERE NO ALARMS THAT OCCURRED. FOLLOWING THE LEAK, A NEW SET OF LINES WAS PRIMED WITH A NEW DIALYZER, AND THE PATIENT¿S TREATMENT WAS RESTARTED ON THE SAME MACHINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 200 TO 300 ML. THE RN CONFIRMED THERE WAS NO PATIENT INJUR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17192176 ↗
• MalfunctionMay 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED AN ARC-SHAPED TEAR/GOUGE OF APPROXIMATELY 5/16" WAS NOTED ON THE BLOOD TUBING'S PUMP SEGMENT DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE MACHINE WAS SET-UP BY AN EXPERIENCED FORMER PATIENT CARE TECHNICIAN (PCT) NOW REGISTERED NURSE (RN). NOTHING SHARP OR ABNORMAL WAS NOTED IN PUMP AREA. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. PHOTOS WERE PROVIDED. THE SAMPLE WAS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858375 ↗
• MalfunctionMar 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT THE COMBISET BLOODLINES BEGAN LEAKING DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. BLOOD SPURT FROM A SPLIT OR HOLE IN THE TUBING THAT WAS LOCATED NEAR THE BLOOD PUMP. ADDITIONAL INFORMATION WAS PROVIDED BY A FACILITY CLINICAL SOCIAL WORKER. THE REPORTED EVENT WAS DISCOVERED APPROXIMATELY ONE HOUR INTO TREATMENT WHEN THE FRESENIUS 2008T MACHINE ALARMED. THE BIOMEDICAL TECHNICIAN (BIOMED) WAS PRESENT AT THE FACILITY AND WENT TO RESPOND TO THE ALARM WHEN A POOL OF BLOOD WAS OBSERVED AT THE BASE OF THE MACHINE. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE PROVIDED. THE PATIENT WAS TRANSFERRED TO A NEW MACHINE WHERE TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE CLINICAL SOCIAL WORKER CONFIRMED THAT A "KNICK" WAS OBSERVED IN THE LINES FOLLOWING THE REPORTED EVENT. NO ISSUES WERE IDENTIFIED WITH THE BLOODLINES DURING PRIME (WITH SALINE). THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE WAS PULLED FROM SERVICE FOR EVALUATION BY THE BIOMED. THE MACHINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564739 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A SMALL LEAK OCCURRED WITH THE COMBISET BLOODLINES DURING THE INITIATION OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS LOCATED WHERE THE TUBING MEETS THE HARD PLASTIC CONNECTOR OF THE VENOUS LINE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. IT WAS NOT STATED UPON INITIAL REPORTING THAT THE PATIENT EXPERIENCED A SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. NO PART WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303958 ↗
• InjuryJan 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE FRESENIUS COMBISET BLOODLINES AND THE CRIT-LINE CLIP (CLIC) ADAPTER. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE CM STATED THAT THE PATIENT REPORTED NOT FEELING WELL APPROXIMATELY 1H42M AFTER THE INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE CM WENT TO CHECK ON THE PATIENT AND IDENTIFIED A BLOOD LEAK AT THE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER AND THE COMBISET BLOODLINES. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 600 ML. THE PATIENT DID NOT COMPLETE TREATMENT THAT DAY. THE PATIENT WAS INSTRUCTED TO GO TO THE HOSPITAL WHERE THEY RECEIVED 1 UNIT (300 ML) OF BLOOD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND NOT ADMITTED. THE PATIENT APPEARED AT THE CLINIC THE FOLLOWING DAY WHERE THEY COMPLETED A FULL ADDITIONAL TREATMENT (WITH A RUNTIME OF 4 HOURS). IT WAS NOTED THAT THE PATIENT¿S HEMOGLOBIN AT THE HOSPITAL WAS 9 (UNITS UNKNOWN) AND THEIR LAST HEMOGLOBIN COUNT TAKEN AT THE CLINIC PRIOR TO THE EVENT WAS 8.5 (UNITS UNKNOWN). THE CM NOTED THAT THE PATIENT¿S HEMOGLOBIN COUNT IS USUALLY ON THE LOW SIDE AND THEY ARE PRESCRIBED ERYTHROP

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16093977 ↗

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