Crit-Line® CL10041021Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00840861100552), received between Dec 19, 2017 and Jun 14, 2026 — classified as 17 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (55 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2026Fluid/Blood Leak

  A NURSE REPORTED THAT THERE WAS BLOOD LEAKING FROM THE DIALYSIS CIRCUIT, WHICH COULD RESULT IN AN INFECTION AND OTHER PATIENT SAFETY RISKS.THE NURSE SAID RECENTLY THERE WAS CIRCUIT LINES LEAKING BLOOD DURING A TREATMENT. TREATMENT WAS PAUSED AFTER THE LEAK. THE CONNECTIONS WERE TIGHTENED AND TREATMENT RESUMED. NEW LINES WERE NOT RESTRUNG. THE PATIENT DID RECEIVE PROPHYLACTIC ANTIBIOTICS. ATTEMPTS WERE MADE TO GATHER MORE DETAILS BUT NO INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25497847 ↗
• MalfunctionJun 14, 2026Fluid/Blood Leak

  A NURSE REPORTED THAT THERE WAS BLOOD LEAKING FROM THE DIALYSIS CIRCUIT, WHICH COULD RESULT IN AN INFECTION AND OTHER PATIENT SAFETY RISKS.THE NURSE SAID RECENTLY THERE WAS CIRCUIT LINES LEAKING BLOOD DURING A TREATMENT. TREATMENT WAS PAUSED AFTER THE LEAK. THE CONNECTIONS WERE TIGHTENED AND TREATMENT RESUMED. NEW LINES WERE NOT RESTRUNG. THE PATIENT DID RECEIVE PROPHYLACTIC ANTIBIOTICS.THE SAMPLE LINES ARE AVAILABLE TO RETURN. ATTEMPTS WERE MADE TO GATHER MORE DETAILS BUT NO INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25497846 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  A REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A CLIC BLOOD CHAMBER LEAKED WITHIN THE FIRST FIVE MINUTES OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOTED THAT BLOOD WAS DRIPPING ONTO THE FLOOR. THE RN SAID THAT ONLY A FEW DROPS OF BLOOD HAD LEAKED OUT. THE LEAK WAS COMING FROM THE CRIT-LINE BLOOD CHAMBER, AT THE GLUED CONNECTION JUST BELOW THE BLOOD CHAMBER BODY. THE RN SAID THERE WERE ALSO HIGH VENOUS PRESSURE ALARMS. UPON FOLLOW-UP WITH THE RN IT WAS REPORTED THAT THIS PATIENT USES SMALL BLOODLINES, AND THEREFORE IT WAS NOT UNUSUAL TO SEE ELEVATED VENOUS PRESSURES IN THE SYSTEM. AIR WAS NOT SUSPECTED TO HAVE ENTERED THE CIRCUIT, AND THERE WERE NO ALARMS TO INDICATE SO. THE BLOOD WAS CLEANED UP, AND THE TREATMENT WAS CONTINUED. HOWEVER, BLOOD CONTINUED TO DRIP OUTSIDE OF THE CHAMBER. WHEN IT WAS NOTED THAT THE LEAKING HAD CONTINUED, THE TREATMENT WAS STOPPED AND THE PATIENT¿S BLOOD WAS RETURNED. THERE WAS NO VISIBLE DAMAGE NOTED AT THE LEAK LOCATION. ADDITIONALLY, THERE WERE NO ISSUES NOTED DURING THE PRIME. ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS MINIMAL. THE RN ESTIMATED PATIENT BLOOD LOSS TO BE 2ML. AS A PRECAUTION, THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24635176 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  A REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT A CLIC BLOOD CHAMBER LEAKED APPROXIMATELY TWENTY-FIVE MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. A DROPLET OF BLOOD WAS NOTED ON THE EXTERIOR OF THE CRIT-LINE BLOOD CHAMBER AT THE GLUED CONNECTION JUST BELOW THE BLOOD CHAMBER BODY. THERE WERE NO MACHINE ALARMS. THE BLOOD WAS WIPED OFF, AND THE TREATMENT WAS ABLE TO BE CONTINUED WITHOUT FURTHER PROBLEMS. THE RN SAID NO NEW BLOOD APPEARED. THERE WAS NO VISIBLE DAMAGE NOTED AT THE LEAK LOCATION. THERE WERE NO ISSUES NOTED DURING THE PRIME. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT WITH THE SAME SETUP. ESTIMATED BLOOD LOSS FROM THE LEAK WAS REPORTEDLY IMMEASURABLE; THE RN ESTIMATED THERE WAS LESS THAN 1ML OF PATIENT BLOOD LOSS. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS 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 24632095 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  A USER FACILITY FACILITY ADMINISTRATOR (FA) REPORTED A CRIT LINE SEPARATION BETWEEN THE DIALYZER AND TWISTER LINE, CAUSING THE PATIENT TO LOSE BLOOD. THE FA REPORTED THE CRIT-LINE DID NOT THREAD EASILY ONTO TWISTER LINES, CAUSING A MALFUNCTION. THE MACHINE ITSELF NEVER ALARMED. UPON FOLLOW-UP, THE FA STATED STAFF OUND THE CRIT LINE UNTWISTED AND DETACHED FROM BETWEEN THE ARTERIAL END OF THE 180NRE DIALYZER (LOT NUMBER UNKNOWN) AND THE BLOOD CHAMBER, AND CAUSED A BLOOD LEAK TO OCCUR. THE FA BELIEVED THE CRIT-LINE DID NOT THREAD EASILY ONTO TWISTER LINES AND SOMEHOW UNTWISTED DURING TREATMENT. THE FA STATED THE EVENT OCCURRED AN HOUR AND A HALF AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE HEMODIALYSIS (HD) MACHINE, A 2008T, MACHINE DID NOT ALARM WITH ANY BLOOD LEAK ALERT. THE PATIENT WAS DIALYZING USING FRESENIUS BLOODLINES. IMMEDIATELY FOLLOWING THE EVENT, TREATMENT WAS HALTED AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 300 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AS A PRECAUTION AND FOR OBSERVATION. THE FA STATED NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT REMAINED STABLE. THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24422870 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED A SMALL CRACK ON THE SIDE OF A CLIC BLOOD CHAMBER THAT WAS CAUSING A SMALL LEAK THAT WAS NOT DETECTED UNTIL THE PATIENT WAS HOOKED UP AND BLOOD WAS MOVING THROUGH THE CIRCUIT. THE CM REPORTED THERE WAS A VERY SMALL CRACK THAT WAS HARD TO VISUALIZE AT FIRST. BLOOD WAS NOT RETURNED. UPON FOLLOW-UP, THE CM CONFIRMED THE REPORTED EVENT AND STATED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE B.BRAUN HEMODIALYSIS MACHINE DID NOT ALARM WITH ANY BLOOD LEAK ALERT. THE BLOOD LEAK WAS VISUALLY OBSERVED FROM A SMALL CRACK ALONG THE SIDE OF THE BLOOD CHAMBER. THE PATIENT WAS DIALYZING USING A FRESENIUS DIALYZER AND B.BRAUN BLOODLINES. THE PATIENT'S BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 10 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED TREATMENT WITHOUT FURTHER ISSUE. THE MACHINE HAS REMAINED IN SERVICE. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE BLOOD CHAMBER WAS AVAILABLE TO BE RETURNED FOR MAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23280847 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED A BLOOD LEAKAGE FROM A CRIT-LINE BLOOD CHAMBER THAT OCCURRED DURING A PATIENT TREATMENT. THE RN REPORTED THE CRIT-LINE BLOOD CHAMBER EXHIBITED A BLOOD LEAKAGE FROM THE SEAM WHERE THE CRIT-LINE CLIC CONNECTS. AS A RESULT, THE TREATMENT WAS HALTED, THE BLOOD WAS RETURNED TO THE PATIENT, AND AN ENTIRELY NEW SETUP WAS IMPLEMENTED, ALLOWING THE TREATMENT TO CONTINUE WITHOUT ANY FURTHER INCIDENTS. THE COMPROMISED BLOOD CHAMBER WAS NOT SAVED AND WAS DISPOSED OF. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED ON (B)(6) 2025 IMMEDIATELY AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT, A BLOOD LEAK WAS OBSERVED FROM THE SEAM WHERE THE CRIT-LINE CLIC CONNECTS. TREATMENT WAS PAUSED AND THE PATIENT¿S BLOOD WAS SUCCESSFULLY RETURNED. PER CM THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS MINIMAL AND DID NOT PROVIDE A QUANTITATIVE VOLUME. THE CM NOTED THAT THE PATIENT REMAINED ASYMPTOMATIC AND CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE. THE MACHINE, A 2008T, WAS NOT EXPECTED TO AND DID NOT ALARM. THE PATIENT WAS UTILIZING FRESENIUS BLOODLINES. NO DAMAGE WAS NOTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23250573 ↗
• MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT DUE TO A CRACK IN A CRIT-LINE CLIP (CLIC) BLOOD CHAMBER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. THERE WAS NO PATIENT INJURY, ADVERSE EVENT 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. 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 19593805 ↗
• MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE RN. THE REPORTED EVENT WAS IDENTIFIED APPROXIMATELY 20 MINUTES AFTER TREATMENT INITIATION WHEN BLOOD WAS VISUALLY OBSERVED DRIPPING FROM THE BLOOD CHAMBER. THE RN COULD NOT STATE WHETHER ANY DEFECT OR DAMAGE WAS NOTED TO THE BLOOD CHAMBER. THERE WERE NO LOOSE CONNECTIONS OR ISSUES IDENTIFIED DURING PRIME. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18130291 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A CRIT-LINE BLOOD CHAMBER LEAKED BLOOD AT THE BEGINNING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOTED THAT BLOOD FLOW WAS INCREASED TO 200 TO 400 AND A TRACE OF BLOOD WAS IN THE DIALYZER HEADER. ONCE THE BLOOD WAS NOTICED, TREATMENT WAS STOPPED AND THE BLOOD CHAMBER WAS SWITCHED OUT. UPON FOLLOW UP, IT WAS CONFIRMED THAT THERE WERE NO MACHINE ALARMS AS IT DOES NOT ALARM FOR MINOR LEAKS. THE PATIENT WAS DIALYZING ON A FRESENIUS 2008T MACHINE AND UTILIZING A FRESENIUS HIGH FLUX DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS APPROXIMATELY 1ML. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IT WAS CONFIRMED THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT ON A NEW MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS REPORTED TO NOT BE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17776373 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE CM DURING FOLLOW-UP. THE BLOOD LEAK OCCURRED APPROXIMATELY TWO HOURS INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT'S TREATMENT WAS SETUP WITH A FRESENIUS 2008T MACHINE AND A FRESENIUS DIALYZER. THE BLOOD LEAK WAS VISUALLY OBSERVED BY A MEMBER OF THE DIALYSIS UNIT. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE CLIC BLOOD CHAMBER. 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. A PROPHYLACTIC WAS ADMINISTERED TO THE PATIENT (VANCOMYCIN, 500 MG, INTRAVENOUSLY (IV), ONE TIME). TREATMENT WAS RESTARTED AND COMPLETED SUCCESSFULLY ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT SAMPLE WAS DISCARDED AND IS UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994690 ↗
• 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 16093942 ↗
• 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 16093903 ↗
• MalfunctionOct 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A CRIT-LINE BLOOD CHAMBER LEAKED A FEW DROPLETS OF BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. DRIED BLOOD WAS NOTED ON TOP OF THE DIALYZER CAP AT THE END OF A PATIENT¿S FOUR AND A HALF HOUR TREATMENT. THE DRIED BLOOD WAS TRACED TO A SECTION OF THE CRIT-LINE BLOOD CHAMBER WHERE A CRACK WAS IDENTIFIED. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE PATIENT WAS DIALYZING ON A GAMBRO PHOENIX MACHINE AND UTILIZING A BAXTER REVACLEAR MAX DIALYZER. THERE WAS NO LEAKAGE DURING THE PRIMING; EVERYTHING HAD SEEMED NORMAL. BLOOD LOSS WAS REPORTEDLY VERY SCANT, AND A PHOTO OF THE BLOOD DROPLETS ON THE DIALYZER WAS PROVIDED FOR REVIEW. ESTIMATED BLOOD LOSS (EBL) WAS REPORTED TO BE 0.5 ML. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IT WAS CONFIRMED THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. THE SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547350 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) AT A USER FACILITY REPORTED THAT A BLOOD LEAK WAS OBSERVED APPROXIMATELY 10 MINUTES PRIOR TO THE COMPLETION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE FA STATED THAT THE REPORTED ISSUE WAS IDENTIFIED DURING A BLOOD PRESSURE CHECK. BLOOD WAS VISUALLY OBSERVED COMING FROM A CRACK ON THE THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER ON THE LARGER BLUE PLASTIC SCREW SIDE AND AT THE CONNECTION BETWEEN THE CLIC BLOOD CHAMBER AND THE DIALYZER. THE FA THOUGHT THE CRACK ON THE CLIC BLOOD CHAMBER WAS CAUSED BY THE DIALYZER BUT WAS NOT CERTAIN. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT ENDED TREATMENT EARLY. THE COMPLAINT DEVICES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURERS FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530100 ↗
• MalfunctionAug 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED TO FRESENIUS VIA VOLUNTARY MEDWATCH # (B)(4) THAT A BLOOD LEAK OCCURRED WITH A CRIT-LINE CLIP (CLIC) BLOOD CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS CAUGHT IMMEDIATELY BY THE STAFF. THE MACHINE, A FRESENIUS 2008T HD SYSTEM, DID NOT ALARM. IT WAS REPORTED THAT THE CLIC BLOOD CHAMBER SEPARATED INTO TWO PARTS. THE BLUE SENSOR DISCONNECTED FROM THE PART THAT CONNECTS WITH THE DIALYZER. THE PATIENT WAS UTILIZING A FRESENIUS DIALYZER AND FRESENIUS BLOODLINES. IT WAS CONFIRMED THAT THE DIALYZER AND BLOODLINES HAD NOT MALFUNCTIONED IN ANY WAY. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE CLIC BLOOD CHAMBER PRIOR TO THE EVENT. THERE WERE NO LOOSE CONNECTIONS OR ISSUES ENCOUNTERED DURING PRIME. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250 ML. IT WAS CONFIRMED THAT 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 WAS COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218506 ↗
• MalfunctionDec 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MEDICAL DIRECTOR REPORTED A BLOOD LEAK ON THE CLIC BLOOD CHAMBER DURING TREATMENT. UPON FOLLOW UP, THE MEDICAL DIRECTOR COULD NOT CONFIRM HOW LONG INTO TREATMENT THE BLOOD LEAK OCCURRED. THE MEDICAL DIRECTOR REPORTED THAT THE LEAK WAS VISUALLY OBSERVED IN THE MIDDLE OF THE CLIC BLOOD CHAMBERS NOT NEAR THE CONNECTION TO THE DIALYZER OR BLOOD LINES. THE MEDICAL DIRECTOR STATED THAT THE PATIENT WAS ON AN OUTSET TABLO MACHINE (SERIAL NUMBER AND CATALOG NUMBER UNKNOWN) AND USING A BAXTER REVACLEAR DIALYZER (PRODUCT NUMBER AND LOT NUMBER UNKNOWN) WITH OUTSET TABLO BLOODLINES (PRODUCT NUMBER AND LOT NUMBER UNKNOWN). THE MEDICAL DIRECTOR CONFIRMED THE PATIENT WAS ABLE TO COMPLETE TREATMENT USING THE SAME MACHINE AND SUPPLIES WITHOUT THE BLOOD CHAMBER ATTACHED. THE MEDICAL DIRECTOR STATED THAT THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE MEDICAL DIRECTOR CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THE MEDICAL DIRECTOR REPORTED THAT THERE WERE NO CHANGES IN THE BLOOD FLOW RATE (BFR). THE MEDICAL DIRECTOR CONFIRMED THAT THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934374 ↗
• MalfunctionDec 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MEDICAL DIRECTOR REPORTED A BLOOD LEAK ON THE CLIC BLOOD CHAMBER DURING TREATMENT. UPON FOLLOW UP, THE MEDICAL DIRECTOR COULD NOT CONFIRM HOW LONG INTO TREATMENT THE BLOOD LEAK OCCURRED. THE MEDICAL DIRECTOR REPORTED THAT THE LEAK WAS VISUALLY OBSERVED IN THE MIDDLE OF THE CLIC BLOOD CHAMBERS NOT NEAR THE CONNECTION TO THE DIALYZER OR BLOOD LINES. THE MEDICAL DIRECTOR STATED THAT THE PATIENT WAS ON AN OUTSET TABLO MACHINE (SERIAL NUMBER AND CATALOG NUMBER UNKNOWN) AND USING A BAXTER REVACLEAR DIALYZER (PRODUCT NUMBER AND LOT NUMBER UNKNOWN) WITH OUTSET TABLO BLOODLINES (PRODUCT NUMBER AND LOT NUMBER UNKNOWN). THE MEDICAL DIRECTOR CONFIRMED THE PATIENT WAS ABLE TO COMPLETE TREATMENT USING THE SAME MACHINE AND SUPPLIES WITHOUT THE BLOOD CHAMBER ATTACHED. THE MEDICAL DIRECTOR STATED THAT THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE MEDICAL DIRECTOR CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THE MEDICAL DIRECTOR REPORTED THAT THERE WERE NO CHANGES IN THE BLOOD FLOW RATE (BFR). THE MEDICAL DIRECTOR CONFIRMED THAT THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934257 ↗
• MalfunctionDec 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY MEDICAL DIRECTOR REPORTED A BLOOD LEAK ON THE CLIC BLOOD CHAMBER DURING TREATMENT. UPON FOLLOW UP, THE MEDICAL DIRECTOR COULD NOT CONFIRM HOW LONG INTO TREATMENT THE BLOOD LEAK OCCURRED. THE MEDICAL DIRECTOR REPORTED THAT THE LEAK WAS VISUALLY OBSERVED IN THE MIDDLE OF THE CLIC BLOOD CHAMBERS NOT NEAR THE CONNECTION TO THE DIALYZER OR BLOOD LINES. THE MEDICAL DIRECTOR STATED THAT THE PATIENT WAS ON AN OUTSET TABLO MACHINE (SERIAL NUMBER AND CATALOG NUMBER UNKNOWN) AND USING A BAXTER REVACLEAR DIALYZER (PRODUCT NUMBER AND LOT NUMBER UNKNOWN) WITH OUTSET TABLO BLOODLINES (PRODUCT NUMBER AND LOT NUMBER UNKNOWN). THE MEDICAL DIRECTOR CONFIRMED THE PATIENT WAS ABLE TO COMPLETE TREATMENT USING THE SAME MACHINE AND SUPPLIES WITHOUT THE BLOOD CHAMBER ATTACHED. THE MEDICAL DIRECTOR STATED THAT THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE MEDICAL DIRECTOR CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE EVENT. THE MEDICAL DIRECTOR REPORTED THAT THERE WERE NO CHANGES IN THE BLOOD FLOW RATE (BFR). THE MEDICAL DIRECTOR CONFIRMED THAT THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934152 ↗
• MalfunctionDec 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT AN EXTERNAL BLOOD LEAK OCCURRED TWO HOURS INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS INITIALLY REPORTED THAT ¿A CRACK¿ WAS FOUND ON THE CLIC BLOOD CHAMBER. UPON FOLLOW-UP, IT WAS REPORTED THAT A COUPLE OF BLOOD DROPLETS WERE IDENTIFIED ON THE HD MACHINE WHICH WERE TRACED TO AN EXTERNAL LEAK FROM THE DIALYZER END CONNECTION OF THE CLIC BLOOD CHAMBER. AN EXTERNAL BLOOD LEAK WAS ALLEGED. REPORTEDLY, THE PATIENT¿S BLOOD HAD SEALED ITSELF OFF AT THE SITE OF THE LEAK. AS A RESULT, THE TREATMENT WAS CONTINUED AND COMPLETED WITH THE SAME SUPPLIES AND ON THE SAME MACHINE. DESPITE THE INITIAL ALLEGATION OF PHYSICAL DAMAGE, FOLLOW-UP CONFIRMED THAT NO CRACKS WERE VISUALLY IDENTIFIED ON THE CLIC BLOOD CHAMBER. THERE WERE NO MACHINE ALARMS ASSOCIATED WITH THE REPORTED FAILURE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 5 ML. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EFFECTS OR REQUIRED MEDICAL INTERVENTION. AS A PROPHYLACTIC MEASURE, THE PATIENT WAS ADMINISTERED AN ANTIBIOTIC INFUSION X1 (FURTHER DETAILS ON THIS WERE NOT PROVIDED). THE CLIC BLOOD CHAMBER WAS NOT AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION. HOWEVER, A PHOTO OF THE DEVICE CONN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913694 ↗
• MalfunctionNov 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS REPORTEDLY COMING FROM ¿THE JUNCTURE OF THE SMOOTH BLUE SECTION AND THE SQUARE BLUE/WHITE SECTION¿. THE SAMPLE WAS DISCARDED DUE TO CONCERNS OVER BLOOD EXPOSURE. IT IS UNKNOWN HOW MUCH BLOOD LOSS THERE WAS AS A RESULT OF THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL, AND THUS FAR, NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817952 ↗
• MalfunctionNov 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS REPORTEDLY COMING FROM ¿THE JUNCTURE OF THE SMOOTH BLUE SECTION AND THE SQUARE BLUE/WHITE SECTION¿. THE SAMPLE WAS DISCARDED DUE TO CONCERNS OVER BLOOD EXPOSURE. IT IS UNKNOWN HOW MUCH BLOOD LOSS THERE WAS AS A RESULT OF THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL, AND THUS FAR, NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817951 ↗
• MalfunctionNov 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLIC BLOOD CHAMBER LEAKED BLOOD DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS REPORTEDLY COMING FROM ¿THE JUNCTURE OF THE SMOOTH BLUE SECTION AND THE SQUARE BLUE/WHITE SECTION¿. THE SAMPLE WAS DISCARDED DUE TO CONCERNS OVER BLOOD EXPOSURE. IT IS UNKNOWN HOW MUCH BLOOD LOSS THERE WAS AS A RESULT OF THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL, AND THUS FAR, NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817948 ↗
• InjuryAug 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS UNDERGOING HD THERAPY WHEN A BLOOD LEAK OCCURRED. TWO HOURS AND FORTY-FIVE MINUTES INTO THE PATIENT'S TREATMENT, THE REGISTERED NURSE (RN) NOTICED BLOOD LEAKING FROM THE TOP OF THE HEMOFLOW F3 DIALYZER (WHERE THE CRIT-LINE DEVICE CONNECTS TO THE DIALYZER). THE ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THE PATIENT¿S HD TREATMENT WAS STOPPED, AND THE RN ATTEMPTED TO RETURN THE PATIENT¿S BLOOD. WHILE RETURNING THE BLOOD, THE PATIENT¿S CENTRAL VENOUS CATHETER LINE CLOTTED (TREATED WITH CATHFLO, GOOD EFFECT), AND APPROXIMATELY 64 ML OF BLOOD COULD NOT BE RETURNED (APPROXIMATE TOTAL EBL = 84 ML). A COMPLETE BLOOD COUNT (CBC) WAS OBTAINED, WHICH REVEALED THE PATIENT¿S HEMOGLOBIN WAS 7.1 GM/DL AND HEMATOCRIT WAS 19.9%. THE DIALYZER WAS REPORTEDLY SEQUESTERED AND STORED FOR EVALUATION/TESTING. AS A RESULT OF THE LEAK, THE NEPHROLOGIST ORDERED ONE UNIT OF PEDIATRIC PACKED RED BLOOD CELLS (150 ML) TO BE ADMINISTERED AT THE NEPHROLOGY CLINIC ON (B)(6) 2021. THE PATIENT WAS TRANSFUSED WITHOUT ISSUE, AND REPEAT LABS SHOWED THE PATIENT¿S HEMOGLOBIN

  Patient problems: Anemia

  MAUDE report 12270722 ↗
• MalfunctionMay 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE MANAGER (NM) REPORTED THAT A BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. WITHIN THE FIRST FIVE MINUTES OF TREATMENT, THERE WERE VENOUS AND ARTERIAL ALARMS OCCURRING. A LEAK WAS SEEN COMING FROM THE CONNECTION OF THE B. BRAUN BLOOD TUBING (THE ARTERIAL LINE) TO THE FRESENIUS CLIC BLOOD CHAMBER. IT WAS REPORTED THAT APPROXIMATELY 15 ML OF BLOOD HAD POOLED ON THE FLOOR IN FRONT OF THE MACHINE. THERE WERE NO VISIBLE PINHOLES FOUND IN THE TUBING AND NO CRACKS ON THE CLIC BLOOD CHAMBER. THE ACCESS WAS CHECKED, AND NO ISSUES WERE FOUND. NO LEAKS WERE NOTED DURING THE PRIMING, AND THE PRODUCTS WERE REPORTED TO BE SET UP CORRECTLY WITH ALL CONNECTIONS PROPERLY TIGHTENED. UPON FURTHER INSPECTION, IT WAS REALIZED THAT THE CLIC DEVICE WAS LOOSE. THE CONNECTION WAS TIGHTENED ¿A FULL HALF TURN¿, BUT THE ALARMS CONTINUED. AFTER THE TROUBLESHOOTING, IT WAS NOTED THAT A CLOT HAD FORMED IN THE VENOUS CHAMBER OF THE BLOODLINE AND THE PATIENT¿S BLOOD COULD NOT BE RETURNED. THE PATIENT LOST THE ENTIRE SYSTEM OF BLOOD. THE PATIENT'S TOTAL ESTIMATED BLOOD LOSS (EBL) WAS 250 TO 300 ML. THE NM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881645 ↗