Crit-Line® CL10041001Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00840861101139), received between Mar 12, 2018 and Jul 1, 2024 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (18 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A CLIC DEVICE WOULD NOT CALIBRATE. A SAMPLE WAS RETURNED FOR EVALUATION AND THERMAL DAMAGE WAS OBSERVED ON THE RECEIVER BOARD. FOLLOW UP WITH THE BMT REVEALED THAT THE CALIBRATION ISSUE OCCURRED DURING SET UP. A PATIENT WAS NOT CONNECTED TO THE DEVICE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED REPORTED THAT HE HAD NO IDEA THAT A THERMAL EVENT OCCURRED. THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BIOMED HAS RECEIVED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. THE CLIC DEVICE WAS RETURNED FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644098 ↗
• MalfunctionJan 19, 2024Inaccurate Information; Inaccurate Information

  A USER FACILITY REGISTERED NURSE (RN) REPORTED TO FRESENIUS THAT THE CRIT-LINE CLIP (CLIC) DEVICE PROVIDED INACCURATE (LOW) HEMATOCRIT (HCT) AND HEMOGLOBIN (HGB) READINGS DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CLIC DEVICE WAS STARTED CORRECTLY BY STAFF AND THE INITIAL READINGS WERE REPORTED TO BE 15.9 HCT AND 5.4 HGB. APPROXIMATELY TWO HOURS INTO TREATMENT THE READINGS WERE RETAKEN AND PROVIDED AS 17.3 HCT AND 5.9 HGB. THE PATIENT'S BLOOD WAS MANUALLY DRAWN AND TESTED AND REVEALED THAT THE PATIENT'S HGB WAS 9.0. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY NOR REQUIRE MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 5 ML. IT WAS INDICATED UPON INITIAL REPORTING THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE DAY OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18546439 ↗
• MalfunctionJan 11, 2024Fire; Melted; Smoking; Fire; Melted; Smoking

  THE HOSPITAL SAFETY QUALITY SPECIALIST REPORTED TO FRESENIUS THAT THE CRIT-LINE CLIP (CLIC) DEVICE CAUGHT FIRE WHILE CONNECTED TO THE POWER ADAPTER OF THE CLM IV MONITOR. THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED EVENT. NO PATIENTS OR INDIVIDUALS WERE HARMED. THE MACHINE WAS PLUGGED IN BUT NOT POWERED ON OR ACTIVELY IN USE WHEN THE REPORTED EVENT OCCURRED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. A NURSE RETURNED TO THE UNIT AND VISUALLY OBSERVED A SMOKING FLAME. UNPLUGGING THE MONITOR FROM THE WALL OUTLET EXTINGUISHED THE FIRE. NO SMOKE DETECTORS WITHIN THE FACILITY WERE TRIGGERED. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. IT WAS NOTED THAT THE CLIC DEVICE WAS PLUGGED INTO THE TOP PLUG OF THE BATTERY PACK AND HAD MELTED. NO ISSUES WERE FOUND WITH THE WALL OUTLET. NO REPAIRS WERE MADE TO THE PRODUCTS. THE PRODUCTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498215 ↗
• MalfunctionAug 15, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A CLIC CRIT-LINE CLIP WON'T CALIBRATE AND CAUSED THE CIRCUIT BOARD TO BURN OUT. UPON FOLLOW-UP, THE BMT STATED THE THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS. THE BMT STATED THERE WAS NO PATIENT INVOLVEMENT, PATIENT HARM, OR ADVERSE EVENT REPORTED. THE BMT STATED THE CIRCUIT BOARD APPEARED BURNT AND CONFIRMED THERE WAS NO SMOKE, FIRE OR BURNING SMELL AS ASSOCIATED WITH THE REPORTED EVENT. THE BMT REPLACED THE CIRCUIT BOARD TO RESOLVE THE REPORTED ISSUE. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND DOES NOT HAVE A PREVIOUS HISTORY OF FAILING AN ELECTRICAL LEAKAGE TEST. THE REPLACED COMPONENT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551670 ↗
• MalfunctionJul 3, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT THAT A CRIT-LINE CLIP (CLIC) DEVICE WOULD NOT POWER ON. UPON FOLLOW UP WITH THE BIOMED, IT WAS STATED THAT THE DEVICE HAD BEEN PREVIOUSLY USED. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE BY THE MANUFACTURER, THERMAL DAMAGE WAS IDENTIFIED ON A FUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252994 ↗
• MalfunctionJun 2, 2022Smoking; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A CRIT-LINE CLIP (CLIC) DEVICE HAD EXPOSED WIRING AND WAS SMOKING. THERE WAS NO REPORTED INJURY OR HARM. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE BIOMED AND A REGISTERED NURSE (RN) FROM THE FACILITY. THE CLIC DEVICE WAS NOT BEING USED AT THE TIME OF THE REPORTED INCIDENT. THE BIOMED STATED THAT THE STAFF TYPICALLY DOES NOT REMOVE IT FROM THE MACHINE. NEITHER THE PATIENT NOR THE TECHNICIAN WAS HARMED. THERE WAS NO INTERRUPTION IN THE PATIENT'S TREATMENT WHEN IT HAPPENED. TO RESOLVE THE ISSUE, THE TECHNICIAN REMOVED IT FROM THE MACHINE. IT WAS UNKNOWN EXACTLY HOW OLD THE CLIC DEVICE WAS. HOWEVER, IT WAS CONFIRMED TO BE OUT OF WARRANTY. THIS WAS KNOWN BECAUSE A COMMUNICATION WITH THE RETURNS DEPARTMENT REVEALED THAT IT WAS TOO OLD TO REPLACE AND A NEW ONE HAD TO BE ORDERED. THE BIOMED DID NOT THINK THE CLIC DEVICE WAS EVER DROPPED OR MISHANDLED IN ANY WAY. IT WAS UNKNOWN HOW LONG THE WIRES WERE EXPOSED FOR. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A CRIT-LINE CLIP (CLIC) DEVICE HAD EXPOSED WIRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14583488 ↗
• MalfunctionApr 6, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A CRIT-LINE CLIP (CLIC) DEVICE WOULD NOT VERIFY. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED. THE BIOMED STATED THE ISSUE WAS DISCOVERED WHEN AT THE BEGINNING OF THE DAY DURING TREATMENT SETUP. THERE IS NO VISIBLE DAMAGE TO THE CLIC DEVICE. THE BIOMED STATED DURING FOLLOW-UP THAT A REPLACEMENT DEVICE HAS BEEN RECEIVED AND THE OLD DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. UPON PHYSICAL EVALUATION OF THE DEVICE BY THE MANUFACTURER, EVIDENCE OF BLOWN FUSE WITH THERMAL DAMAGE WAS IDENTIFIED ON THE POWER SUPPLY BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14036172 ↗
• MalfunctionNov 7, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO CUSTOMER SERVICE (CS) THAT A CLIC DEVICE WOULD NOT VERIFY. THE BIOMED CONFIRMED THE DEFECTIVE DEVICE WAS PREVIOUSLY INSTALLED AND PROVIDED TREATMENT DATA; THIS WAS NOT AN OUT-OF-BOX FAILURE. A REPLACEMENT DEVICE WAS ISSUED TO THE FACILITY. IT WAS CONFIRMED THAT THE REPLACEMENT DEVICE WAS RECEIVED, AND THE DEFECTIVE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON PHYSICAL EVALUATION OF THE RETURNED DEVICE BY THE MANUFACTURER, EVIDENCE OF THERMAL DAMAGE WAS IDENTIFIED ON THE POWER SUPPLY BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760634 ↗
• MalfunctionJun 2, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CRIT-LINE CLIP (CLIC) DEVICE WOULD NOT VERIFY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE A RESPONSE HAS NOT BEEN RECEIVED. THE CLIC DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN INTERNAL INSPECTION OF THE CLIC DEVICE REVEALED CORROSION AND THERMAL DAMAGE TO THE TRANSMITTER BOARD AND TO THE INSIDE OF THE TRANSMITTER COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924104 ↗
• MalfunctionApr 11, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A CRIT-LINE CLIP (CLIC) DEVICE WOULD NOT VERIFY. ADDITIONAL INFORMATION WAS PROVIDED BY THE BIOMED DURING FOLLOWUP. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT REGARDING THE REPORTED ISSUE. ANOTHER CLIC DEVICE WAS USED FOR TREATMENT. THE SAMPLE WAS RETURNED TO THE MANUFACTURER. DURING A PHYSICAL EVALUATION, CORROSION WAS IDENTIFIED ON THE RECEIVER BOARD AND THERE WAS EVIDENCE OF THERMAL DECOMPOSITION AND CORROSION ON THE POWER BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646916 ↗
• MalfunctionMar 16, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO CUSTOMER SERVICE (CS) THAT THE CLIC DEVICE HAD NO POWER. A REPLACEMENT DEVICE WAS ISSUED TO THE FACILITY. UPON FOLLOW-UP, THE BIOMED CONFIRMED THAT THE DEVICE WAS PREVIOUSLY USED. NO PATIENT INVOLVEMENT WAS ASSOCIATED WITH THE REPORTED ISSUE. IT WAS CONFIRMED THAT THE REPLACEMENT DEVICE WAS RECEIVED, AND THE DEFECTIVE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON PHYSICAL EVALUATION OF THE RETURNED DEVICE BY THE MANUFACTURER, EVIDENCE OF HEAT DAMAGE WAS FOUND ON COMPONENTS LOCATED ON THE RECEIVER BOARD AND THE POWER SUPPLY BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497034 ↗
• MalfunctionJul 14, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMED TECHNICIAN (BIOMED) REQUESTED A PART NUMBER FOR THE FUNCTION BOARD ON THE 2008T MACHINE. THE BIOMED TECHNICIAN REPORTED ISSUES WITH THE P41 CABLE GROUND POST GETTING A BURNT SPOT. IN ADDITION, THE SIDE USB PORT IS EXPOSED WHEN THE CLIC IS NOT CONNECTED. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE PROVIDED THE REQUESTED PART NUMBER, AND ADVISED THE BIOMED TECHNICIAN TO HAVE THE SIDE USB COVER/FLAP CLOSED WHEN THE PORT IS NOT IN USE. THE BIOMED TECHNICIAN WAS INFORMED THAT FLUID MAY BE GETTING IN THE PORT WHEN THE MACHINE IS WIPED DOWN, RESULTING IN AN ISSUE NEAR THE P41 CONNECTION. UPON FOLLOW-UP WITH THE BIOMED, IT WAS REPORTED THAT THE FUNCTION BOARD HAD A BURN SPOT DUE TO A SHORT. IT WAS REPORTED THAT THE CRIT LINE CABLE WIRING CAUSED THE SHORT/BURN SPOT ON THE BOARD. THE BIOMED CONFIRMED THAT THERE WAS NO BURNING SMELL, MELTING, SMOKE, SPARK, OR FLAME, ONLY THAT IT APPEARED TO BE DISCOLORED AND BURNED. THERE WAS NO OTHER PHYSICAL DAMAGE ON THE BOARD ITSELF. THE ISSUE WAS NOTED DURING NORMAL REPAIR. THE MACHINE HAD NO PAST PROBLEMS FAILING THE ELECTRICAL LEAKAGE TEST AND THERE WERE NO OTHER DAMAGED COMPONENTS NOTED. THE MACHINE WAS NOT PLUGGED INTO A HOS

  Patient problems: No Patient Involvement

  MAUDE report 10273257 ↗
• MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THE CLIC DEVICE HAS LOOSE UNSEALED FILTER AND BLOOD WAS OBSERVED IN THE FILTER. THE BIOMED STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE BIOMED STATED THAT HE OBSERVED 3 DROPS ON THE FILTER THE BIOMED STATED THAT THEY WERE UNABLE TO PROVIDE ANY OTHER INFORMATION AS THE BLOOD LEAK WAS DISCOVERED AFTER THE PATIENT HAD DISCONNECTED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9245315 ↗
• MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT THE CLIC DEVICE HAD BLOOD ON WHITE PAPER INSIDE THE FILTER. THE BIOMED STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE BIOMED STATED THAT THEY WERE UNABLE TO PROVIDE ANY OTHER INFORMATION AS THE BLOOD LEAK WAS DISCOVERED AFTER THE PATIENT HAD DISCONNECTED. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE NOT PROVIDED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244643 ↗
• MalfunctionSep 30, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS CRIT-LINE CLIP (CLIC) - USB WOULD NOT VERIFY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER TO DATE HAS NOT BEEN PROVIDED. THE CLIC WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON PHYSICAL EVALUATION, CHARRED MARKS ON THE POWER SUPPLY BOARD AROUND THE FUSE AND FERRITE WERE IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9135231 ↗
• MalfunctionSep 9, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY REPORTED THAT THE CLIC DEVICE WILL NOT VERIFY. AFTER CONTACTING THE CUSTOMER, IT WAS CONFIRMED THAT THE REPLACEMENT DEVICE WAS RECEIVED. THIS ISSUE WAS NOT AN OUT OF BOX FAILURE EITHER AS IT HAS BEEN INSTALLED ON THE MACHINE FOR A DURATION OF TIME PRIOR TO THIS INCIDENT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. UPON PHYSICAL EVALUATION OF THE CLIC DEVICE, AN INTERNAL SHORT ON C104 AND C102 OF THE POWER SUPPLY BOARD WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8976378 ↗
• MalfunctionDec 13, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS CRIT-LINE CLIP (CLIC) DEVICE WAS VERY HOT TO THE TOUCH WHEN PLUGGED IN. DURING MANUFACTURER FAILURE ANALYSIS, HEAT DAMAGE AND AN UNKNOWN SUBSTANCE WERE NOTED ON THE CLIC DEVICE¿S TRANSMITTER BOARD. IT WAS CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED TRANSMITTER BOARD.

  Patient problems: No Patient Involvement

  MAUDE report 8161687 ↗
• MalfunctionDec 6, 2018Sparking; Sparking

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS CRIT-LINE CRIP (CLIC) DEVICE SPARKED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE CLIC BECAME VERY HOT AND UPON INSPECTION OF THE DEVICE BY STAFF, IT SPARKED. THE CLIC DEVICE WAS UNPLUGGED IMMEDIATELY AND TREATMENT WAS CONTINUED ON THE SAME MACHINE. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE SPARKING CLIC DEVICE. ADDITIONAL PATIENT AND EVENT DETAILS WERE REQUESTED, BUT HAVE NOT BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137331 ↗
• MalfunctionDec 5, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY REPORTED A FRESENIUS CRIT LINE CLIP THAT WOULD NOT VERIFY ANY INFORMATION. IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. UPON INSPECTION, HEAT DAMAGE AND CORROSION WAS FOUND ON A RESISTOR ON THE RECEIVER BOARD. A REPLACEMENT CRIT LINE CLIP WAS RECEIVED AT THE CLINIC TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8134568 ↗
• MalfunctionNov 14, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED A CLIC DEVICE THAT WOULD NOT CALIBRATE PRIOR TO ANY TREATMENT. IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND AN INTERNAL INSPECTION SHOWED VISIBLE THERMAL DAMAGE TO THE RECEIVER BOARD.

  Patient problems: No Patient Involvement

  MAUDE report 8071193 ↗
• MalfunctionAug 23, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED A CLIC DEVICE WITH A BURNED INTERNAL CIRCUIT BOARD. THE ISSUE WAS DISCOVERED WHEN THE CLIC DEVICE BECAME HOT TO THE TOUCH. THERE WERE NO VISIBLE FLAME, SMOKE, SPARK, ARCING, OR BURNING SMELLS REPORTED. UPON RETURN TO THE MANUFACTURER, VISIBLE BURN DAMAGE WAS DISCOVERED ON THE TRANSMITTER BOARD. DUE DILIGENCE ATTEMPTS WERE EXHAUSTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7808470 ↗
• MalfunctionAug 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED CLIC DEVICE BLOOD LEAK AT AN UNSPECIFIED POINT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING OBSERVED VISUALLY IN THE CLIC DEVICE AFTER TREATMENT. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. ADDITIONAL PATIENT AND DEVICE INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7743444 ↗
• MalfunctionJul 24, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS CRIT LINE CLIP (CLIC) DEVICE WAS NOT COMMUNICATING WITH A HEMODIALYSIS MACHINE. THE DEVICE WAS RETURNED TO THE MANUFACTURER, WHERE IT WAS DETERMINED THAT THERE WAS HEAT DISCOLORATION ON COMPONENTS OF THE DEVICE¿S POWER SUPPLY BOARD. THE HEAT DAMAGED COMPONENTS WERE FOUND DURING FAILURE ANALYSIS OF THE DEVICE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE NONFUNCTIONAL CLIC DEVICE. THE BIOMED REPLACED THE CLIC DEVICE, WHICH RESOLVED THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7713535 ↗
• MalfunctionJul 11, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT CLIC CRIT-LINE CLIP DEVICE WOULD DID NOT SHOW THE LED LIGHT WHEN IT WAS ACTIVATED. THIS WAS DETERMINED TO BE CAUSED BY HEAT DAMAGE ON THE POWER SUPPLY BOARD AND THE RECEIVER BOARD. THE ISSUE WAS NOTICED PRIOR TO USE, AND A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE CLIC DEVICE. THE BIOMED REPLACED THE CLIC DEVICE WITH A NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7676849 ↗
• MalfunctionJun 21, 2018Overheating of Device; Overheating of Device

  BIOMED TECHNICIAN AT A HEMODIALYSIS CLINIC REPORTED THAT THE CRIT-LINE CLIP (CLIC) - USB DEVICE WAS OVERHEATING AND NOT FUNCTIONING. FOLLOW UP WITH THE BIOMED TECHNICIAN INDICATED THE ALLEGATION OCCURRED DURING TREATMENT. THE ALLEGED DEVICE WAS REMOVED FROM THE DIALYSIS MACHINE AND IT WAS HOT TO THE TOUCH. PATIENT TREATMENT CONTINUED WITHOUT INTERRUPTION OR COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624898 ↗