Extension Set with EASY-LOCK Connector 5C4480CRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00085412087382), received between Apr 6, 2018 and May 14, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Component Missing

  IT WAS REPORTED THAT THE CLEAR PULL RING CAP ON THE EXTENSION SET WAS MISSING. THIS WAS IDENTIFIED BEFORE OPENING THE PACKAGING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174792 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A 12 FOOT EXTENSION SET EASY LOCK ¿ CONNECTOR LEAKED. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059565 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL FOUR OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. THERE WAS FLUID ON THE FLOOR. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH ENDING THERAPY. THE PATIENT WOULD DRAIN MANUALLY. PROPER PROCEDURES PER THE USER MANUAL REVIEWED WITH THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365955 ↗
• MalfunctionFeb 13, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAPS WERE MISSING ON AN UNSPECIFIED QUANTITY OF EXTENSION SETS. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337328 ↗
• MalfunctionFeb 11, 2026Component Missing

  IT WAS REPORTED THAT THE PATIENT LINE CAP WAS MISSING ON AN UNSPECIFIED QUANTITY OF EXTENSION SETS (REPORTED AS "SEVERAL"). THE ISSUE WAS DESCRIBED AS BRAND-NEW PATIENT EXTENSION LINE IN A SEALED PACKAGE ¿DID NOT HAVE A CAP ON THE PATIENT CONNECTION SIDE¿. THIS WAS IDENTIFIED WHEN PATIENT WAS BEGINNING SET UP OF THE MACHINE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314059 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT TWO (2) HOLES/SLITS WERE FOUND IN THE LINE OF A 12 FOOT PATIENT LINE EXTENSION SET WHICH CAUSED A LEAK DESCRIBED AS; ¿THERE WAS A POOL OF FLUID ON THE FLOOR¿. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER, THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074736 ↗
• MalfunctionAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE THERE WAS AN INCH CUT AT THE END OF THE BLUE END OF THREE (3) EXTENSION SETS. THIS WAS NOTICED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728744 ↗
• InjuryAug 5, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A LEAK FROM A PATIENT EXTENSION LINE. IT WAS REPORTED THAT THERE WAS "HOLES/SLITS IN PATIENT EXTENSION LINE" AND NOTICED A "POOL OF FLUID ON THE FLOOR". IT WAS FURTHER REPORTED THAT THE PATIENT EXTENSION LINE HAD A DEFECT DESCRIBED AS A PINHOLE. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH PERITONITIS 3 DAYS AFTER THE REPORTED LEAK. THE CAUSE OF THE PERITONITIS WAS REPORTED AS UNKNOWN. ON THE SAME DATE AS THE DIAGNOSIS, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS. THE PATIENT WAS TREATED WITH UNSPECIFIED MEDICATION. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE EVENT. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Peritonitis

  MAUDE report 22722520 ↗
• MalfunctionMay 15, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE EXTENSION SET AND MINICAP TRANSFER SET. THE EXTENSION SET DISCONNECTED FROM THE TRANSFER SET LEAVING THE TRANSFER SET UNCLAMPED AND EXPOSED. THIS OCCURRED AT THE END OF SECOND FILL DURING PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT RECEIVED A THREE-DAY ANTIBIOTIC TREATMENT PROTOCOL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028922 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET). THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL THREE OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNKNOWN LOCATION. THERE WAS FLUID ON THE FLOOR. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH ENDING THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882358 ↗
• MalfunctionOct 9, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT LINE EXTENSION SET HAD A HOLE. THIS WAS NOTICED DURING SET UP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE PATIENT STARTED OVER WITH NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408756 ↗
• MalfunctionSep 19, 2024Disconnection; Protective Measures Problem; Disconnection; Protective Measures Problem

  IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN AN EXTENSION SET AND THE PATIENT LINE OF THE HOMECHOICE CASSETTE THAT LED TO A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN ONE OF FOUR OF PERITONEAL DIALYSIS (PD) THERAPY. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH CLEARING THE ALARM AND ADVISED THE PATIENT CONTACT THEIR NURSE REGARDING THE ISSUE. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262505 ↗
• MalfunctionDec 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 12 FOOT EXTENSION SET LEAKED WHERE THE TUBING MEETS THE WHITE CONNECTOR. THE TUBING WAS NOT PLACED ONTO THE PATIENT EXTENSION CONNECTOR PIECE CORRECTLY AND THE END OF THE TUBING WAS EXPOSED ALLOWING THE FLUID TO LEAK BETWEEN THE TUBING AND WHITE CONNECTOR COMPONENTS. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291280 ↗
• MalfunctionDec 7, 2023Fluid/Blood Leak; Material Puncture/Hole; Protective Measures Problem; Fluid/Blood Leak; Material Puncture/Hole; Protective Measures Problem

  IT WAS REPORTED THAT THERE WERE HOLES IN AN EXTENSION SET WHICH RESULTED IN A LEAK THAT LED TO A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN TWO OF FIVE OF PERITONEAL DIALYSIS (PD) THERAPY. RENAL THERAPY SERVICES ASSISTED THE PATIENT WITH ENDING THE THERAPY SESSION AND REVIEWED PROPER PROCEDURES PER THE USER MANUAL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287336 ↗
• MalfunctionSep 11, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A 12 FOOT EXTENSION SET HAD A HOLE IN THE TUBING WHICH RESULTED IN A LEAK. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719491 ↗
• MalfunctionFeb 1, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A 12 FOOT EXTENSION SET WAS LEAKING. THIS WAS FURTHER DESCRIBED AS THE HOME PATIENT (HP) ¿NOTICED A SOLUTION LEAK AND FOUND A PINHOLE¿ (PIN SIZE HOLE) ON THE PATIENT LINE OF THE EXTENSION SET. THIS OCCURRED DURING THE FIRST FILL OF AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. THE HP WAS CONNECTED AT THE TIME OF THE EVENT. RENAL THERAPY SERVICES (RTS) ASSISTED THE HP IN ENDING THE THERAPY SESSION AND IN CASSETTE REMOVAL. THE HP WILL START THE THERAPY SESSION OVER WITH ALL NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419146 ↗
• MalfunctionJul 2, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CLIPS (CLAMP) WERE MISSING AT THE END OF AN UNSPECIFIED QUANTITY OF 12 FOOT EXTENSION SETS (PATIENT LINE). THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112101 ↗
• MalfunctionMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT EXTENSION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569138 ↗
• MalfunctionMar 7, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN AN UNSPECIFIED QUANTITY OF PATIENT EXTENSION SETS. IT WAS FURTHER SPECIFIED THAT "ONCE THE SOLUTION PASSED THE CONNECTION PART OF THE EXTENSION SET, BUBBLES APPEARED." THE EXTENSION SETS WERE TIGHTLY CONNECTED. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426637 ↗
• MalfunctionFeb 16, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE FEMALE CONNECTOR OF A TRANSFER SET "CAME OFF FROM THE LUER LOCK" OF A PATIENT LINE EXTENSION SET. THIS WAS FURTHER DESCRIBED AS ¿THE PATIENT GOT UP TO GO TO THE BATHROOM IN THE MIDDLE OF THE NIGHT WHILE CONNECTED TO HOMECHOICE CYCLER, PATIENT PICKED UP EXTENSION LINE TO MOVE OUT OF THE WAY AND LINE FELL APART AT THE ADAPTOR¿. THIS OCCURRED DURING PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11333600 ↗
• MalfunctionFeb 12, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN AN UNSPECIFIED QUANTITY OF PATIENT EXTENSION SETS. IT WAS FURTHER SPECIFIED THAT "ONCE THE SOLUTION PASSED THE CONNECTION PART OF THE EXTENSION SET, BUBBLES APPEARED." THE EXTENSION SETS WERE TIGHTLY CONNECTED. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11325594 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SIX (6) PATIENT LINE EXTENSION SETS WERE LEAKING. THE LEAKS WERE OBSERVED FROM THE PATIENT LINE CONNECTOR END OF THE SET DURING PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11273219 ↗
• MalfunctionOct 9, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE WHITE CAP OF A 12 FOOT EXTENSION SET WAS MISSING. IT WAS FURTHER REPORTED THAT THE CAP WAS NOT IN THE PACKAGING AND NOT IN THE SHIPPING CARTON. THIS WAS FOUND BEFORE PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10659004 ↗
• MalfunctionSep 25, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT AN EXTENSION SET LEAKED DUE TO HOLES IN THE TUBING; FURTHER DESCRIBED AS "2 HOLES ON ONE SIDE OF THE TUBING AND 1 HOLE ON THE OTHER SIDE", BELOW THE CONNECTION POINT. THIS WAS NOTICED DURING FILL OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE PATIENT WAS GIVEN ANTIBIOTICS AS PROPHYLAXIS TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10589575 ↗
• MalfunctionJul 21, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT EXTENSION SET LEAKED; FURTHER DESCRIBED AS ¿LEAK WAS COMING OUT OF A PUNCTURE, NEAR THE AREA WITH THE WHITE END THAT CONNECTS TO THE PATIENT PORTAL. THIS WAS OBSERVED DURING USE OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY, HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AS PRECAUTIONARY MEASURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305739 ↗