CLM IV MONITOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS OBTAINED FROM A FIELD SERVICE TECHNICIAN (FST) ON JANUARY 30 2026. THE FST VISITED THE CLINIC ON (B)(6) 2026 TO EVALUATE THE EQUIPMENT, HOWEVER THE POINT OF CONTACT WAS OFF ON THAT DAY, THEY WERE UNABLE TO SEE THE UNITS INVOLVED IN THIS INCIDENT. A NURSE WAS ABLE TO CALL THE POINT OF CONTACT FOR ADDITIONAL INFORMATION. IT WAS REPORTED THAT THIS INCIDENT COULD HAVE BEEN AVOIDED ALTOGETHER IF NECESSARY SAFETY PRECAUTIONS WERE TAKEN. IT WAS REPORTED THAT THE MONITORS ARE GENERALLY MOUNTED ON THE IV POLE OF THE DIALYSIS MACHINES DIRECTLY UNDER SALINE BAGS. ACCORDING TO THE NURSE¿S STATEMENT, THE POWER ADAPTER WAS MOUNTED WITH THE AC CORD (POWER PLUG) FACING IN THE UPWARDS DIRECTION AND SALINE WAS DRIPPING OVER THE POWER CORD PLUG AND SALINE INTRUDED THE POWER ADAPTER INTERNALS VIA AC PLUG AND CAUSED THE POWER ADAPTER TO SHORT CIRCUIT AND CATCH FIRE. THE STAFF REPLACED THE POWER ADAPTERS AND MOUNTED THE NEW POWER ADAPTERS WITH THE AC POWER CORD FACING DOWN TO PREVENT FUTURE INCIDENTS OF THIS NATURE. THE EVENT WAS REPORTED TO BE CAUSED BY USE ERROR. THERE WAS NO PRODUCT MALFUNCTION, AND THERE WERE NO SERIOUS INJURIES OR DEATH REPORTED.

Description of Event or Problem

A USER FACILITY'S DIALYSIS TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SOME TIME LAST YEAR A CLM IV MONITOR¿S POWER CORD CAUGHT FIRE. UPON FOLLOW UP, THE DIALYSIS TECHNICIAN SAID THAT THE ISSUE OCCURRED ON (B)(6) 2025. THE CRIT-LINE MONITOR (CLM) SERIAL NUMBER IS UNKNOWN. IT IS UNKNOWN WHEN THE FIRE OCCURRED. THE FIRE WAS CAUSED BY THE POWER SUPPLY. A SMOKE SMELL WAS NOTED BY AN OVERNIGHT EMPLOYEE. THE SMOKE ALARMS DID NOT GO OFF. THERE WAS NO DAMAGE TO ANY OTHER COMPONENTS AS A RESULT OF THIS ISSUE. THE CLM IS PLUGGED IN TO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE ISSUE WAS RESOLVED BY REPLACING THE POWER CORD. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. THERE WERE NO SAMPLES AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY'S DIALYSIS TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SOME TIME LAST YEAR A CLM IV MONITOR¿S POWER CORD CAUGHT FIRE. UPON FOLLOW UP, THE DIALYSIS TECHNICIAN SAID THAT THE ISSUE OCCURRED ON (B)(6) 2025. THE CRIT-LINE MONITOR (CLM) SERIAL NUMBER IS UNKNOWN. IT IS UNKNOWN WHEN THE FIRE OCCURRED. THE FIRE WAS CAUSED BY THE POWER SUPPLY. A SMOKE SMELL WAS NOTED BY AN OVERNIGHT EMPLOYEE. THE SMOKE ALARMS DID NOT GO OFF. THERE WAS NO DAMAGE TO ANY OTHER COMPONENTS AS A RESULT OF THIS ISSUE. THE CLM IS PLUGGED IN TO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE ISSUE WAS RESOLVED BY REPLACING THE POWER CORD. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. NO SAMPLE IS AVAILABLE. FIVE PHOTOGRAPHS HAVE BEEN PROVIDED.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND AN ON-SITE EVALUATION WAS NOT PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). HOWEVER, FIVE PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED. IN PHOTOS 1 TO 4, THERMAL DECOMPOSITION WAS OBSERVED AS A RESULT OF A FIRE CAUSED BY A SHORT CIRCUIT IN A POWER SUPPLY THAT HAD BEEN INSTALLED UPSIDE DOWN. THE MANUFACTURER WAS ABLE TO DETERMINE A CAUSAL RELATIONSHIP BETWEEN THE OBJECTIVE EVIDENCE PROVIDED BY THE CUSTOMER AND THE REPORTED EVENT. AS A SERIAL NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE REPORTED EVENT HAS BEEN CONFIRMED.

Description of Event or Problem

A USER FACILITY'S DIALYSIS TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SOME TIME LAST YEAR A CLM IV MONITOR¿S POWER CORD CAUGHT FIRE. UPON FOLLOW UP, THE DIALYSIS TECHNICIAN SAID THAT THE ISSUE OCCURRED ON (B)(6) 2025. THE CRIT-LINE MONITOR (CLM) SERIAL NUMBER IS UNKNOWN. IT IS UNKNOWN WHEN THE FIRE OCCURRED. THE FIRE WAS CAUSED BY THE POWER SUPPLY. A SMOKE SMELL WAS NOTED BY AN OVERNIGHT EMPLOYEE. THE SMOKE ALARMS DID NOT GO OFF. THERE WAS NO DAMAGE TO ANY OTHER COMPONENTS AS A RESULT OF THIS ISSUE. THE CLM IS PLUGGED IN TO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE ISSUE WAS RESOLVED BY REPLACING THE POWER CORD. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE. THERE WERE NO SAMPLES AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.