Crit-Line® 191058Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840861102020), received between Jun 14, 2017 and Jun 7, 2018 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  HEMODIALYSIS CLINIC CONTACT REPORTED THAT A CRIT-LINE III BLOOD CHAMBER POPPED OFF THE TOP OF THE DIALYZER DURING HEMODIALYSIS TREATMENT, RESULTING IN PATIENT BLOOD LOSS. IT IS UNKNOWN IF THERE WAS MEDICAL INTERVENTION. THE VOLUME OF BLOOD LOSS IS UNKNOWN. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: Blood Loss

  MAUDE report 7579725 ↗
• MalfunctionJan 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT LEAST HALF-WAY THROUGH A PATIENT HEMODIALYSIS (HD) TREATMENT WITH A FRESENIUS 2008K MACHINE, A STAFF MEMBER AT THE USER FACILITY ACCIDENTLY BUMPED INTO THE CRIT-LINE CLIP DEVICE THAT WAS ATTACHED TO THE BLOODCHAMBER, WHICH LOOSENED THE BLOODCHAMBER CONNECTION TO THE DIALYZER CAUSING AN EXTERNAL BLOOD LEAK. THERE WAS VISIBLE BLOOD DRIPPING DOWN THE DIALYZER. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 4ML AND THERE WAS NO CHANGE IN THE PATIENT STATUS. THE STAFF RE-TIGHTENED THE CONNECTION BETWEEN THE BLOODCHAMBER AND DIALYZER, AND THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR ADVERSE REACTION REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ALLEGATION OF A DEFECT OR MALFUNCTION REGARDING THE BLOODCHAMBER OR DIALYZER DEVICES. THE NURSE REPORTED THAT THE MACHINE MAY HAVE ALARMED, BUT WAS UNSURE. FOLLOWING THE EVENT, THE MACHINE WAS REMOVED FROM SERVICE TO BE CLEANED. THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ANY FURTHER ISSUE AS REPORTED. THE DIALYZER WAS AN OPTIFLUX F200 OR F250, BUT NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFAC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7192889 ↗
• InjuryNov 30, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A (B)(6) WHITE, FEMALE, END STAGE RENAL DISEASE (ESRD) STAGE 4 PATIENT HAD BEEN UTILIZING HEMODIALYSIS (HD) THERAPY THREE TIMES PER WEEK SINCE (B)(6) 2017 FOR PRE-TRANSPLANT TREATMENT. THE PATIENT WAS SCHEDULED TO HAVE TRANSPLANT DURING THE UPCOMING WEEK. APPROXIMATELY 5 MINUTES INTO THE HD TREATMENT ON (B)(6) 2017 DURING A SCHEDULED 120-MINUTE HD TREATMENT VIA CATHETER LINES RUNNING ARTERIAL-ARTERIAL AND VENOUS-VENOUS, THE REGISTERED NURSE (RN) NOTICED A SMALL BLOOD LEAK IN CIRCUIT WHERE THE CRIT-LINE BLOOD CHAMBER AND ARTERIAL LINE (MEDISYSTEMS HEMODIALYSIS BLOOD TUBING) MEET. THE LEAK WAS NOT ALLEVIATED BY TIGHTENING OF THE CONNECTION. THE BLOOD CHAMBER WAS REMOVED FROM CIRCUIT AND THE BLOOD LINE WAS ATTACHED DIRECTLY TO DIALYZER WITH NO FURTHER LEAKING NOTED. THE ESTIMATED BLOOD LOSS WAS REPORTEDLY LESS THAN 3ML AND THERE WAS NO CHANGE IN THE PATIENT STATUS. THE PATIENT COMPLETED HER 120 MINUTES OF SCHEDULED HD TREATMENT. HOWEVER, PER FACILITY POLICY OF THE REPORTED OPEN CIRCUIT, BLOOD CULTURES WERE DRAWN AND EMPIRIC VANCOMYCIN 200 MG INTRAVENOUS (IV) ONE TIME AND CIPROFLOXACIN 250 MG VIA GASTROINTESTINAL TUBE (G-TUBE) (FOR 3 DAYS), WAS ADMINISTERED POST HD

  Patient problems: Blood Loss; Rash

  MAUDE report 7071864 ↗
• MalfunctionJul 5, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S ADMINISTRATIVE ASSISTANCE REPORTED THAT A PATIENT EXPERIENCED BLOOD LOSS WHILE UNDERGOING HEMODIALYSIS (HD) TREATMENT ON A 2008K2 HD MACHINE. THE FOLLOWING DETAILS WERE PROVIDED. THE CRIT-LINE III BLOODCHAMBER II DEVICE DISCONNECTED FROM THE OPTIFLUX F200NR DIALYZER WITH 15 TO 20 MINUTES LEFT IN THE HD TREATMENT. THE BLOOD WITHIN THE ARTERIAL LINE OF THE EXTRACORPOREAL CIRCUIT WAS RETURNED AND THE HD THERAPY WAS DISCONTINUED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 520 MILLILITERS (ML). THE PATIENT'S CONDITION WAS FINE. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. NO MALFUNCTION OF THE 2008K2 HD MACHINE WAS OBSERVED OR IDENTIFIED, PRIOR TO, DURING, OR FOLLOWING THE HD TREATMENT. THERE WAS NO ALLEGATION THAT A BLOODLINE MALFUNCTION OCCURRED. THE MACHINE, DIALYZER, BLOODLINES, AND BLOOD CHAMBER WERE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6688774 ↗
• MalfunctionJun 30, 2017Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  A USER FACILITY¿S NURSE MANAGER REPORTED THAT A BLOOD LEAK OCCURRED ON THE BLOOD CHAMBER OF THE CRIT-LINE III BLOODCHAMBER II DEVICE 5-10 MINUTES AFTER INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK OCCURRED WHERE THE CRIT-LINE SCREWS INTO THE HEAD OF THE DIALYZER. NO CRACKS WERE VISIBLE ON THE CRIT-LINE MODULE, THE COMPLAINANT INDICATED IT AS BEING A CONNECTION ISSUE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 25 CUBIC CENTIMETERS (CC). THE NURSE WAS ABLE TO TIGHTEN THE CONNECTION TO RESOLVE THE ISSUE, AND THEN THE HD THERAPY WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY ISSUES. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE CRIT-LINE III BLOODCHAMBER II WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6681882 ↗
• MalfunctionJun 20, 2017Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  A REGISTERED NURSE AT THE USER FACILITY REPORTED THAT THREE (3) HOURS INTO A FOUR (4) HOUR TREATMENT, A FRESENIUS CRIT-LINE BLOOD CHAMBER COMPLETELY DISCONNECTED FROM A GAMBRO REVACLEAR DIALYZER AND 200 CUBIC CENTIMETERS (CC) OF BLOOD WAS LOST. TREATMENT WAS STOPPED AND THE CRIT-LINE BLOOD CHAMBER WAS REPLACED WITH A NEW ONE. THE PATIENT COMPLETED TREATMENT WITHOUT ANY ILL EFFECTS, ADVERSE EVENTS OR MEDICAL INTERVENTION. THE MACHINE WAS NOT REMOVED FROM SERVICE FOLLOWING THIS INCIDENT. NO SAMPLES WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6653966 ↗
• MalfunctionJun 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S NURSE MANAGER REPORTED THAT THERE WAS A BLOOD LEAK OCCURRED ON THE BLOOD CHAMBER OF THE CRIT-LINE III BLOOD CHAMBER II DEVICE HALFWAY THROUGH A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE LEAK OCCURRED WHERE THE CRIT-LINE SCREWS INTO THE HEAD OF THE DIALYZER. NO CRACKS WERE VISIBLE ON THE CRIT-LINE III MODULE, THE COMPLAINANT INDICATED IT AS BEING A CONNECTION ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 200 MILLILITERS (ML). THE PATIENT WAS RE-SET UP WITH A NEW BLOODLINE, DIALYZER, AND BLOOD CHAMBER, AND THEN THE HD THERAPY WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY ISSUES. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641340 ↗
• MalfunctionJun 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S NURSE MANAGER REPORTED THAT THERE WAS A BLOOD LEAK OCCURRED ON THE BLOOD CHAMBER OF THE CRIT-LINE III BLOOD CHAMBER II DEVICE 5-10 MINUTES AFTER INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK OCCURRED WHERE THE CRIT-LINE SCREWS INTO THE HEAD OF THE DIALYZER. NO CRACKS WERE VISIBLE ON THE CRIT-LINE III MODULE, THE COMPLAINANT INDICATED IT AS BEING A CONNECTION ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 25-50 CUBIC CENTIMETERS (CC). THE NURSE ATTEMPTED TO RE-SEAT THE CRIT-LINE III MODULE WITHOUT SUCCESS. THE PATIENT WAS RE-SET UP WITH A NEW BLOODLINE, DIALYZER, AND BLOOD CHAMBER, AND THEN THE HD THERAPY WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY ISSUES. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE CRIT-LINE III BLOOD CHAMBER II AND THE OPTIFLUX DIALYZER ASSEMBLY WERE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS BOTH DEVICES WERE DISCARDED BY THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641143 ↗