NexSite HD Hemodialysis Catheter NEXHD1553201Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05391525640044), received between Sep 3, 2015 and Sep 12, 2017 — classified as 1 death, 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2017Inaccurate Flow Rate

  DATE OF THIS REPORT: TYPO (YEAR) CORRECTED. DATABASE RECONCILIATION OF STUDY (B)(6): THE INADEQUATE FLOW CONTINUED UNTIL (B)(6) 2016 WHEN THE DEVICE WAS REMOVED BECAUSE IT WAS NO LONGER REQUIRED.

  Patient problems: No Code Available

  MAUDE report 6857315 ↗
• MalfunctionJun 15, 2017Inaccurate Flow Rate

  (B)(4). THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT EXPERIENCED A LOW FLOW EVENT THAT WAS MILD IN SEVERITY. TREATMENT FOR THE EVENT INCLUDED ALTEPLASE. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. THE EVENT HAD RESOLVED ON THE SAME DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642653 ↗
• InjuryMay 22, 2017Adverse Event Without Identified Device or Use Problem

  CONCLUSION OF THE CEC (CLINICAL EVENTS COMMITTEE) FOLLOWING ADJUDICATION OF THE ADVERSE EVENT: OTHER- FEVER OF UNKNOWN ETIOLOGY - BLOOD CULTURES NEGATIVE BEFORE ANTIBIOTIC ADMINISTRATION. BLOOD CULTURES WERE DRAWN AT 14.40 AND 15.00 ON (B)(6) 2017. VANCOMYCIN WAS INITIALLY ADMINISTERED AT 15.00 ON (B)(6) 2017.

  Patient problems: Chills; Fever; Unspecified Infection

  MAUDE report 6581032 ↗
• MalfunctionApr 27, 2017Restricted Flow rate; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POOR CATHETER FLOW INITIALLY OCCURRED ON (B)(6) 2017. THIS WAS TREATED WITH CATHFLO ACTIVASE AND NO ACTION WAS TAKEN WITH THE STUDY DEVICE. THE EVENT RESOLVED WITH SEQUELAE ON (B)(6) 2017. THE SECOND EVENT OF POOR CATHETER FLOW OCCURED ON (B)(6) 2017 AND RESULTED IN DEVICE REMOVAL ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525391 ↗
• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem

  CONCLUSIONS OF THE CEC (CLINICAL EVENTS COMMITTEE) FOLLOWING ADJUDICATION OF THE ADVERSE EVENT: CRBSI WITH EXIT SITE INFECTION.

  Patient problems: Alteration In Body Temperature; Fever; Staphylococcus Aureus; Test Result

  MAUDE report 6383304 ↗
• InjuryDec 12, 2016Complete Blockage

  THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT EXPERIENCED A CLOTTED CATHETER. CATHFLO WAS GIVEN IN AN ATTEMPT TO DE-CLOT. THE DEVICE WAS REMOVED ON (B)(6) 2016 AND THE EVENT RESOLVED.

  Patient problems: No Information

  MAUDE report 6165679 ↗
• InjuryNov 29, 2016Adverse Event Without Identified Device or Use Problem

  STUDY (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. THE TIP OF THE CATHETER WAS POSITIONED IN THE SVC. THE PROCEDURE REPORT FROM THE CATHETER PLACEMENT PROCEDURE STATES THAT THE PATIENT HAD A RECLOTTED LEFT UPPER ARM AVG. THE PHYSICIAN ADVISED NO MORE DECLOT ATTEMPTS AND HE PLANS A NEW RIGHT ARM AV ACCESS ASAP. HE HAS HAD MULTIPLE CHEST CATHETERS PREVIOUSLY. THE PATIENT RECEIVED CATHFLO ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A DYSFUNCTIONAL LEFT INTERNAL JUGULAR VEIN TDC (TUNNELLED DIALYSIS CATHETER). THE CURRENT CATHETER TIP IS IN THE SVC AND WE DO NOT HAVE A CATHETER THE APPROPRIATE LENGTH TO REACH THE RIGHT ATRIUM. CLOTTED ACCESS WAS INDICATED. A RIJ CATHETER COULD NOT BE PLACED DUE TO IJ STENOSIS. DECISION IS MADE WITH THE PATIENT TO PLACE A FEMORAL CATHETER FOR HD ACCESS. "THERE WAS NOTHING WRONG WITH THE DEVICE. THE SUBJECT HAD IJ STENOSIS AND NEEDED A LONGER CATHETER FOR PLACEMENT." THE NEXSITE HD CATHETER WAS REMOVED AND THE EVENT HAD RESOLVED ON (B)(6) 2016.

  Patient problems: Stenosis

  MAUDE report 6131298 ↗
• InjurySep 13, 2016Material Separation

  STUDY (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016 TO REPLACE A DEVICE (NON-NEXSITE) THAT HAD CLOTTED. ON (B)(6) 2016, THE PATIENT HAD A FEVER. HE ATTENDED THE EMERGENCY DEPARTMENT ON (B)(6) 2016. RIGHT UPPER CHEST DIALYSIS CATHETER HAD SOME MILD SWELLING. PER THE HOSPITAL NOTE, THE SUBJECT'S LABS SHOWED LEUKOCYTOSIS AND NO CLEAR SOURCE OF THE INFECTION WAS IDENTIFIED. THERE WAS CONCERN ABOUT THE CATHETER BEING THE SOURCE OF THE INFECTION. VANCOMYCIN AND GENTAMACIN WERE GIVEN TO TREAT THE SUSPECTED CRBSI AND THE PATIENT WAS SENT HOME TO BE SEEN AT DIALYSIS THE NEXT DAY. WHEN THE SUBJECT ARRIVED TO THE ACCESS UNIT ON (B)(6) 2016, VASCULAR STAFF NOTED THAT THE SUBJECT WAS VERY LETHARGIC WITH AN ELEVATED TEMPERATURE. THE VASCULAR STAFF SENT THE SUBJECT TO THE LOCAL EMERGENCY DEPARTMENT TO RECEIVE IV ANTIBIOTICS. WHEN THE SUB-INVESTIGATOR WENT TO THE EMERGENCY DEPARTMENT TO REMOVE THE CATHETER, IT WAS NOTED THAT THE DACRON SKIRT HAD SEPARATED FROM THE INSERTED DISC. THE DACRON SKIRT WAS OUTSIDE OF THE CATHETER EXIT SITE. THE PATIENT WAS ADMITTED TO HOSPITAL AND IV DAPTOMYCIN WAS GIVEN. THE EVENT WAS RESOLVING.

  Patient problems: Unspecified Infection

  MAUDE report 5945206 ↗
• InjuryAug 11, 2016Appropriate Device Problem Term/Code Not Available

  (B)(6): THE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2016. ON (B)(6) 2016, THIS PATIENT PRESENTED WITH SHINGLES (SEVERE) WHICH WAS CONSIDERED UNRELATED TO THE DEVICE AND WAS TREATED WITH SULFATE CREAM - GENTAMYCIN AND VALTREX AND THE EVENT RESOLVED ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS DOCUMENTED TO HAVE AN ALTERED MENTAL STATE OF MODERATE SEVERITY WHICH WAS NOT CONSIDERED RELATED TO THE STUDY DEVICE AND RESOLVED ON THE SAME DAY WITHOUT TREATMENT. THE STAFF AT THE CLINIC NOTED ON (B)(6) 2016 THAT THE PATIENT HAD A FEVER OF 40+ DEGREES CELSIUS WITH SHAKING RIGORS. BLOOD CULTURES WERE DRAWN. ON (B)(6) 2016, THE PATIENT HAD THE DEVICE REMOVED DUE TO BACTEREMIA OF MODERATE SEVERITY WHICH IS CONSIDERED UNLIKELY RELATED TO THE STUDY DEVICE. IT WAS THOUGHT THAT THE SOURCE OF THE INFECTION WAS MOST LIKELY FROM SKIN CONTAMINATE OF HERPES ZOSTER THE SUBJECT SUFFERED FROM IN THAT AREA. TREATMENT FOR THE BACTEREMIA INCLUDED LEVAQUIN, ZOSYN AND VANCOMYCIN. THE BACTEREMIA HAD RESOLVED ON (B)(6) 2016. THE HOSPITAL DISCHARGE NOTE FROM (B)(6) 2016 NOTED THAT THE TUNNEL CATHETER WAS CLEAN AND DID NOT APPEAR INFECTED. THE FINAL RESULTS FOR WHOLE BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCC

  Patient problems: Bacterial Infection; Confusion/ Disorientation; Fever; Herpes; Shaking/Tremors; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 5867926 ↗
• MalfunctionApr 1, 2016Insufficient Flow or Under Infusion

  (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2015. ON (B)(6) 2016, MILD POOR FLOW OF THE STUDY DEVICE WAS REPORTED. NO ACTION WAS TAKEN WITH THE STUDY DEVICE. CATHFLO ACTIVASE WAS GIVEN TO TREAT THE EVENT. THE EVENT RESOLVED ON THE SAME DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5540599 ↗
• InjuryFeb 15, 2016Insufficient Device Problem Information

  (B)(6): THE NEXSITE DEVICE WAS SUCCESSFULLY PLACED ON (B)(6) 2015. ON (B)(6) 2016, THERE WAS PAIN AND ERYTHEMA AT CATHETER EXIT SITE. VANCOMYCIN WAS GIVEN TO TREAT THE EVENT. CENTRAL BLOODS WERE TAKEN ON (B)(6) 2016 AND WERE FOUND TO BE NEGATIVE. NO ACTION WAS TAKEN WITH THE STUDY DEVICE.

  Patient problems: Erythema; Pain

  MAUDE report 5436196 ↗
• MalfunctionDec 8, 2015Device Operates Differently Than Expected

  TR 0147: THIS PATIENT HAD A NEXSITE DEVICE PLACED SUCCESSFULLY ON (B)(6) 2015. THE DEVICE WAS REMOVED ON (B)(6) 2015 DUE TO MILD CATHETER MALFUNCTION. NO OTHER TREATMENT WAS GIVEN AND THE EVENT RESOLVED.

  Patient problems: No Code Available

  MAUDE report 5273707 ↗
• DeathSep 3, 2015Incorrect Or Inadequate Test Results

  STUDY (B)(4): THIS NEXSITE DEVICE WAS IMPLANTED SUCCESSFULLY ON (B)(6) 2015. THE PHYSICIAN DOCUMENTED THAT THE PATIENT HAD A NEGATIVE BLOOD CULTURE BEFORE PLACEMENT. ON (B)(6) 2015, THE PATIENT HAD BLOOD CULTURES DRAWN FOR SURVEILLANCE. THE BLOOD CULTURES WERE (B)(6) FOR (B)(6) INFECTION AND IT WAS REPORTED THAT THE PATIENT HAD RELAPSING CATHETER ASSOCIATED (B)(6) BACTEREMIA. THE PATIENT WAS AFEBRILE AND ASYMPTOMATIC. THE PATIENT WAS STARTED ON VANCOMYCIN ON (B)(6) 2015 AND CONTINUED UNTIL (B)(6) 2015. HE HAD ALSO BEEN GIVEN DAPTOMYCIN AS AN OUTPATIENT. THE PATIENT HAD NEGATIVE BLOOD CULTURES ON (B)(6) 2015. BLOOD CULTURES DRAWN IN DIALYSIS ON (B)(6) 2015 AND AGAIN ON (B)(6) 2015 WERE (B)(6) FOR (B)(6). DUE TO DEGREE OF ANAEMIA, HYPOALBUMINEMIA AND (B)(6) BLOOD CULTURES, THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2015 FOR EVALUATION AND TREATMENT OF CATHETER-RELATED BLOODSTREAM INFECTION. THE CATHETER WAS REMOVED ON (B)(6) 2015 AND VANCOMYCIN WAS GIVEN. INFECTIOUS DISEASE CONSULTANT WANTED THE CATHETER REMOVED AND SUSPECTED HE SEEDED HIS BLOOD FROM AN UNKNOWN SOURCE, SO THIS WAS A "BYSTANDER / COLLATERAL DAMAGE " SITUATION. IT WAS FELT THAT PATIENT HAD DEVELOPED A BLOODSTREAM

  Patient problems: Bacterial Infection; Staphylococcus Aureus

  MAUDE report 5053044 ↗