NIAGARA

Description of Event or Problem

IT WAS REPORTED THAT THE DIALYSIS MACHINE (FRESENIUS MULTIFILTRATE) REGULARLY GAVE AN AIR ALARM. IT WAS OBVIOUSLY DRAWING AIR. THIS WAS EVIDENT FROM THE MACHINE'S BUBBLE TRAP. THE DIALYSIS DEPARTMENT WAS ALSO CONSULTED. THE CATHETER WAS ALSO VISUALLY INSPECTED SEVERAL TIMES; NO MACROSCOPIC ABNORMALITIES COULD BE DETECTED. ON (B)(6) 2025, IT WAS DECIDED TO CHANGE THE DIALYSIS CATHETER. ASERVATION OF IT. I EXAMINED THE CATHETER BY CLASSIC "SQUEEZING"; SALINE WAS DRIPPING FROM THE TRANSITION FROM THE HUB TO THE INTRAVASCULAR PART OF THE CATHETER. THIS WOULD EXPLAIN THE DRAWING OF AIR. THE NIAGARA CATHETER WAS USED ON THE PATIENT IN THE PERIOD FROM (B)(6) 2025. NO ADDITIONAL MEDICAL INTERVENTION/MEDICATION WAS REQUIRED. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A LEAK IN THE CATHETER IS CONFIRMED, BUT THE ROOT CAUSE COULD NOT BE DETERMINED. ONE 24 CM NIAGARA SLIMCATH CATHETER WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE RETURNED CATHETER SHOWED BLOOD RESIDUES THROUGHOUT THE DEVICE. BLOOD RESIDUES WERE OBSERVED ALONG THE CATHETER UNDER THE SUTURE WINGS. A FUNCTIONAL TEST OF ATTEMPTING TO INFUSE WATER INTO EACH LUMEN OF THE CATHETER USING A 12 ML SYRINGE REVEALED THE BLUE LUMEN TO BE PATENT TO INFUSION WITH NO OBSERVED LEAKS, WHILE THE RED LUMEN WAS OBSERVED TO LEAK UNDER THE MOLDED JOINT ALONG THE CATHETER SHAFT. A MICROSCOPIC OBSERVATION REVEALED A SPLIT UNDER THE PROXIMAL MOLDED BIFURCATION BETWEEN THE MOLDED JOINT AND THE WINGS OF THE CATHETER. THE SPLIT WAS OBSERVED TO HAVE A SEPTUM OF CATHETER, MAKING THE SPLIT APPEAR AS TWO HOLES BESIDE EACH OTHER. THE FRACTURE SURFACE APPEARED SMOOTH, AND THE FRACTURE EDGES APPEARED TO GRADUALLY FORM INTO THE SPLIT. ADDITIONAL DETAILS OF THE SPLIT COULD NOT EASILY BE SEEN DUE TO THE LOCATION OF THE SPLIT AND THE LIGHT COLORATION OF THE CATHETER SHAFT. THE EXACT CAUSE OF THIS FAILURE COULD NOT BE DETERMINED; HOWEVER, POSSIBLE CAUSES MAY INCLUDE BENDING, TWISTING, OR KINKING OF THE CATHETER SHAFT RUBBING AGAINST THE SPLIT LOCATION, OR OTHER UNKNOWN CIRCUMSTANCES. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.