Effluent Sample Bag 5C4476Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00085412007717), received between Jun 4, 2019 and Sep 13, 2024 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (53 reports).

4 other recalls cover devices cleared under the same FDA submission (K923065); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED. THIS OCCURRED DURING PRIMING FOR PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. THE LEAK WAS DESCRIBED AS THE "EFFLUENT SAMPLE BAG WAS RESTING ON THE FLOOR AND AS THE PRIMING BEGAN, THEY NOTICED A PUDDLE STARTING TO DEVELOP JUST UNDER THAT SAMPLE BAG". AS A RESULT, "THEY CLAMPED THAT SMALL TUBING LEADING TO THE BAG AND PLACED AN ABSORBENT PAD UNDER IT". THE SAMPLE BAG WAS REMOVED AND THE TRAINING WAS RESUMED. 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 20213795 ↗
• MalfunctionMar 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED. IT WAS FURTHER DESCRIBED THAT "AS SOON AS THE FLUID HIT THE BAG, THE BAG STARTED DRIPPING". IT WAS ALSO STATED THAT "THE SEAM WAS NOT TIGHT AND THAT IT LOOKED AS IF THE SEAL BETWEEN THE LINE AND THE BAG WAS COMPROMISED." THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THIS OCCURRED DURING USE OF THE PRODUCT 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 18897338 ↗
• InjurySep 18, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE PERITONEAL DIALYSIS (PD) TRANSFER SET AND EFFLUENT SAMPLE BAG WHICH RESULTED IN PERITONITIS. WHILE ATTEMPTING TO REMOVE AN EFFLUENT SAMPLE BAG FROM THE AFFECTED TRANSFER SET, IT WAS OBSERVED THAT THE FEMALE CONNECTOR WAS COMING LOOSE FROM THE LIGHT BLUE MAINBODY OF THE TRANSFER SET. THE NURSE WAS TAKING AN EFFLUENT SAMPLE FROM THE PATIENT AND WAS REMOVING SAMPLE BAG WHICH WAS ON SO TIGHT UPON TWISTING NOTICED THE BLUE TIP OF THE TRANSFER SET WAS UN-THREADING RATHER THAN THE SAMPLE BAG PORT. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAPERITONEAL ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. THE TRANSFER SET WAS REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Peritonitis

  MAUDE report 17768729 ↗
• MalfunctionJun 27, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG WAS DAMAGED. THIS WAS FURTHER DESCRIBED AS ¿THE PORT CAME COMPLETELY OFF ONTO THE SYRINGE¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14830992 ↗
• MalfunctionJun 17, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED. THE BAG WAS NOT SEALED CAUSING A LEAK AT THE "MEDICATION" PORT. THIS OCCURRED DURING A PRODUCT DEMONSTRATION. THERE WERE NO SIGNS OF PHYSICAL DAMAGE TO THE PRODUCT OR SHIPPING MATERIALS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14738226 ↗
• MalfunctionMar 8, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT ONE (1) EFFLUENT SAMPLE BAG WAS DISCOLORED (AMBER LIKE COLOR) AT THE SEAMS. THIS WAS OBSERVED DURING USE 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 13698294 ↗
• MalfunctionMar 8, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT ELEVEN (11) EFFLUENT SAMPLE BAGS WERE DISCOLORED (AMBER LIKE COLOR) AT THE SEAMS. THIS WAS OBSERVED PRIOR TO USE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698083 ↗
• MalfunctionApr 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED. THIS WAS OBSERVED WHEN DRAINING THE PATIENT OF EFFLUENT. DURING FOLLOW UP, THE NURSE REPORTED THE LEAK WAS "RIGHT NEXT TO THE MEDICATION PORT". THE NURSE DID NOT NOTICE ANY PHYSICAL DAMAGE ON THE BAG. 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 11681161 ↗
• MalfunctionApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 3 EFFLUENT SAMPLE BAGS WERE LEAKING NEAR THE PORT WHERE MEDICATIONS ARE ADDED. THE CUSTOMER REPORTED THAT THEY WENT THROUGH THREE BAGS TRYING TO COLLECT AN EFFLUENT SAMPLE AND EACH ONE LEAKED NEAR THE PORT WHERE MEDICATION IS ADDED. ADDITIONALLY, IT WAS REPORTED THAT IT APPEARED THAT THE PLASTIC ON THE BAG WAS NOT SEALED RESULTING IN THE LEAKS. THE LEAKS WERE DISCOVERED DURING PERITONEAL DIALYSIS (PD) 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 11637703 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED AT THE SEAM CLOSE TO THE MEDICATION PORT. THIS OCCURRED PRIOR TO EFFLUENT COLLECTION. 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 11592277 ↗
• MalfunctionMar 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) EFFLUENT SAMPLE BAGS LEAKED AT THE CONNECTION TO THE TRANSFER SET. A THIRD BAG WAS USED WITH NO FURTHER ISSUES. THIS WAS OBSERVED DURING PATIENT DRAINING. 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 11585140 ↗
• MalfunctionNov 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EFFLUENT SAMPLE BAG LEAKED. THIS OCCURRED DURING USE OF PERITONEAL DIALYSIS THERAPY. THE LEAK WAS IDENTIFIED ON THE SLITS. 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 10824242 ↗
• MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EFFLUENT SAMPLE BAG LEAKED. THIS OCCURRED DURING USE OF PERITONEAL DIALYSIS THERAPY. THE LEAK WAS IDENTIFIED "ON THE SLITS". 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 10813098 ↗
• MalfunctionNov 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG WAS LEAKING AT THE SEAM NEAR THE MEDICATION PORT. THE LEAK WAS DISCOVERED AT THE CLINIC WHILE COLLECTING AN EFFLUENT SAMPLE AND THE BAG APPEARED TO NO HAVE BEEN SEALED PROPERLY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT, HOWEVER, THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795533 ↗
• MalfunctionNov 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EFFLUENT SAMPLE BAG LEAKED; FURTHER DESCRIBED AS ¿FLUID WAS LEAKING OUT OF THE PORT¿. THIS OCCURRED 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 Consequences Or Impact To Patient

  MAUDE report 10771763 ↗
• MalfunctionOct 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG WAS LEAKING. WHILE THE PATIENT WAS DRAINING INTO THE EFFLUENT SAMPLE BAG AT THE CLINIC, IT WAS REPORTED THAT THE SITE NEXT TO THE PORT WAS LEAKING. THE NURSE STATED THAT THE BAG DID NOT LOOK LIKE IT HAD BEEN SEALED IN ALL THE WAY. 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 10729500 ↗
• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED; FURTHER DESCRIBED AS "LEAKING ALONG TOP SEAM BETWEEN THE 2 (TWO) PORTS." THIS WAS NOTICED AT THE CLINIC DURING A CYCLER SET UP PRACTICE DEMONSTRATION FOR PERITONEAL DIALYSIS (PD) THERAPY. THE LEAK WAS NOTED WHILE THE CYCLER WAS RUNNING, AND THE PATIENT WAS NOT CONNECTED. IT WAS REPORTED THAT THE BAG WAS CONNECTED TO THE SMALL DRAIN LINE PORT THAT NORMALLY CONNECTS TO THE SAMPLE BAG. 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 10576333 ↗
• MalfunctionJun 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 2 EFFLUENT SAMPLE BAGS LEAKED. THIS OCCURRED DURING PATIENT USE. THE NURSE STATED IT STARTED LEAKING FROM THE PORT USED FOR INJECTIONS. 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 10154100 ↗
• MalfunctionJun 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK COMING FROM THE EFFLUENT SAMPLE BAG. THIS OCCURRED DURING PATIENT USE. THE NURSE STATED IT STARTED LEAKING FROM THE PORT USED FOR INJECTIONS. 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 10154062 ↗
• MalfunctionApr 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) EFFLUENT BAGS LEAKED FROM ¿THE SEAM AROUND THE MEDICATION PORT.¿ THIS WAS OBSERVED DURING USE OF PERITONEAL DIALYSIS THERAPY. 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 9923085 ↗
• MalfunctionApr 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) EFFLUENT BAGS LEAKED FROM ¿THE SEAM AROUND THE MEDICATION PORT¿. THIS WAS OBSERVED DURING USE OF PERITONEAL DIALYSIS THERAPY. 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 9922506 ↗
• MalfunctionMar 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) PD EFFLUENT SAMPLE BAGS LEAKED. THIS OCCURRED DURING USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THE LEAKS WERE LOCATED AT BOTH THE MEDICATION PORT AND THE CONNECTION POINT OF THE EFFLUENT BAGS AND THE TRANSFER SET. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AND THE TRANSFER SET WAS CHANGED AS PRECAUTIONARY MEASURES. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9872165 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG HAD A SMALL CUT WHICH RESULTED IN A LEAK. THIS WAS NOTICED 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 Consequences Or Impact To Patient

  MAUDE report 9805705 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) EFFLUENT SAMPLE BAGS WERE LEAKING. A HEALTHCARE PROFESSIONAL (HCP) WAS PERFORMED A PERITONEAL EQUILIBRATION TEST (PET) WITH A PATIENT UTILIZING THE EFFLUENT SAMPLE BAG. THE HCP WAS RE-INSTILLING THE SAMPLE WHEN THEY NOTED SOLUTION DROPS LEAKING FROM THE BAG AT THE SEAL THAT ENCASES THE EFFLUENT SAMPLE BAG LINE AND THE MEDICATION PORT. THE CUSTOMER ATTEMPTED THE PROCESS WITH ANOTHER EFFLUENT SAMPLE BAG; HOWEVER, THE LEAKS WERE OBSERVED WITH THE SECOND DEVICE AS WELL. THE PATIENT WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS (CEFAZOLIN INTRAPERITONEALLY). 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 9746562 ↗
• MalfunctionFeb 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EFFLUENT SAMPLE BAG LEAKED. THIS OCCURRED DURING EFFLUENT COLLECTION. IT WAS FURTHER DESCRIBED THAT THE BAG WAS LEAKING WHERE THE TUBING GOES INTO THE BAG. THE BAG WAS NOT FUSED PROPERLY CAUSING A LEAK AT THE "MEDICATION" PORT. 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 9746100 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923065. One submission often covers many models, so check the product and lot details in each record.

• Z-2132-2012 · Jul 6, 2012 · Terminated
  Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufa
• Z-0946-2008 · Nov 20, 2007 · Terminated
  Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, D
• Z-1018-05 · Jun 21, 2005 · Terminated
  HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C447
• Z-1012-04 · May 24, 2004 · Terminated
  HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C447