Caresite® 354221Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 04046964182372), received between Jan 9, 2017 and Sep 25, 2026 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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. 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 25, 2026Air/Gas in Device

  As reported by the user facility:End user reported air bubbles in the line, which is causing their machines to alert. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896573 ↗
• MalfunctionApr 22, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING CHEMO ADMINISTRATION THE FILTER LEAKED. THE NURSE REPORTS THAT ALL CONNECTIONS TO THE LINES AND BAG WERE SECURE AND THE LEAK WAS VISIBLY COMING FROM THE FILTER OF THE FILTERED EXTENSION SET. SHE VISUALLY INSPECTED, AND COULD NOT SEE ANY NOTICEABLE BREAKS IN THE PLASTIC OR FILTER AREA SO NOT ENTIRELY SURE HOW THIS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955548 ↗
• MalfunctionMar 30, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3: INPATIENT ONCOLOGY HOOKED UP TWO INFUSOMAT PUMP FOR HYDRATION THROUGH THE PORT LINE, DRUG VIA THE LOWER Y-SITE. LEAKAGE WAS OBSERVED AT THE ONGUARD SYRINGE ADAPTOR, SPECIFICALLY WHERE THE IV LINE CONNECTS AND THEY HAVE A FILTERED EXTENSION SET THAT STARTED TO BUBBLE AT THE AIR ELIMINATING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713671 ↗
• MalfunctionMar 30, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: INPATIENT ONCOLOGY HOOKED UP TWO INFUSOMAT PUMP FOR HYDRATION THROUGH THE PORT LINE, DRUG VIA THE LOWER Y-SITE. LEAKAGE WAS OBSERVED AT THE ONGUARD SYRINGE ADAPTOR, SPECIFICALLY WHERE THE IV LINE CONNECTS AND THEY HAVE A FILTERED EXTENSION SET THAT STARTED TO BUBBLE AT THE AIR ELIMINATING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713330 ↗
• MalfunctionMar 30, 2026Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: INPATIENT ONCOLOGY HOOKED UP TWO INFUSOMAT PUMP FOR HYDRATION THROUGH THE PORT LINE, DRUG VIA THE LOWER Y-SITE. LEAKAGE WAS OBSERVED AT THE ONGUARD SYRINGE ADAPTOR, SPECIFICALLY WHERE THE IV LINE CONNECTS AND THEY HAVE A FILTERED EXTENSION SET THAT STARTED TO BUBBLE AT THE AIR ELIMINATING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713168 ↗
• MalfunctionJan 22, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WHEN INFUSING CHEMO TO PATIENT, THE NURSE NOTICED FLUID WAS LEAKING OUT OF THE HOLES OF THE FILTER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24156914 ↗
• MalfunctionJan 6, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: DURING THERAPY TO ADMINISTER EPOC OVER 24 HOURS IN OUR B-CELL LYMPHOMA PATIENTS. WE HAVE NOTICED DRUG LEAKING FROM THE AIR HOLES ON THE FILTER 2 TWICE LAST WEEK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975344 ↗
• MalfunctionJan 6, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: DURING THERAPY TO ADMINISTER EPOC OVER 24 HOURS IN OUR B-CELL LYMPHOMA PATIENTS. WE HAVE NOTICED DRUG LEAKING FROM THE AIR HOLES ON THE FILTER 2 TWICE LAST WEEK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974228 ↗
• MalfunctionJul 17, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: WE HAD 2 INCIDENTS OF FILTER EXTENSION SET 0.2 MICRON FILTER LEAKING WITH CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529603 ↗
• MalfunctionJul 17, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: WE HAD 2 INCIDENTS OF FILTER EXTENSION SET 0.2 MICRON FILTER LEAKING WITH CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529602 ↗
• MalfunctionMay 30, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: "AIR IN THE LINE BELOW THE FILTER". WHEN IT WAS REPORTED TO US, WE WERE TOLD THAT THEY NOTICED THE AIR AND CHANGED THE TUBING BEFORE ANYTHING REACHED THE PATIENT. DURING A FOLLOW UP, IT WAS STATED THAT THE PATIENT WAS VERY ILL IN THE NICU AND THAT THE DEATH IS NOT RELATED TO OUR PRODUCT OR THIS REPORTED EVENT. NURSE MANAGER OF THE PEDIATRIC CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU), PROVIDED ADDITIONAL INFORMATION RELATED TO THIS EVENT. WHILE THE EVENT WAS INITIALLY REPORTED ALONGSIDE A PATIENT DEATH, IT WAS CONFIRMED THAT THE AIR DID NOT REACH THE PATIENT AND WAS NOT A CONTRIBUTING FACTOR IN THE PATIENT'S DEATH. THE DEATH WAS ATTRIBUTED TO THE PATIENT'S UNDERLYING COMPLEX MEDICAL CONDITION AND WAS NOT RELATED TO DEVICE PERFORMANCE OR FAILURE. BASED ON THIS MEDICAL CLARIFICATION, THIS EVENT DOES NOT MEET THE REPORTING CRITERIA FOR A SERIOUS INJURY OR DEATH UNDER 21 CFR 803.50 (A)(1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117655 ↗
• MalfunctionFeb 21, 2025Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE LINE WAS NOTED TO HAVE BLOOD IN THE CHEMOTHERAPY IV TUBING LINE. THE IV TUBING LINE APPEARED TO HAVE AIR GAPS IN THE LINE AND WAS LEAKING, ALL CLAMPS ON THE CHEMOTHERAPY LINE WERE CLAMPED, THE LINE WAS COVERED WITH A CHEMO MAT. THE LINE WAS THEN NOTED TO HAVE BEEN TORN/BROKEN WHERE THE FILTER WAS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432238 ↗
• MalfunctionJun 7, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: PHARMACIST REPORTED DURING A LIVE CALL (DURATION: THAT THE EXT SET W/ CARESITE & FILTER WAS NOTED, ABOUT 2 HOURS INTO THE INFUSION TO BE LEAKING. CHEMO MEDS WERE NOTES ON THE FLOOR, THE LEAKAGE DID NOT FALL ON THE PATIENT. SPILL NOTED AND CLEANED UP; ABOUT LESS THAN 10ML SPILLED FROM MEDICATION. THE LEAKAGE WAS NOTED TO OCCUR FROM THE FILTER ITSELF AND NOT FROM THE CONNECTION. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THIS IS THE SECOND OCCURRENCE SINCE INITIAL REPORT ON (B)(6) 2024. CUSTOMER REPORTS THAT FOR DRUGS THEY DO NOT TRACK THEIR LOTS. CUSTOMER SHOULD BE ABLE TO GET THE LOT NUMBER AS THEY ARE TRACKING FOR THE ADMINISTRATION OF TAXOL FOR OTHER PURPOSES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483840 ↗
• MalfunctionMay 24, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE EVENT DESCRIPTION: THE EXT SET W/ CARESITE & FILTER, PART # 354221 IS LEAKING AT THE CONNECTION NEAR THE CLOSED SYSTEM. THE LEAKING WAS NOTED BY THE NURSED. WHEN THESE ARE DISPENSED, THEY ARE PUT IN CHEMO PROTECTION BAGS WITH NO LEAKING NOTED UNTIL THE BAGS ARE HUNG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392426 ↗
• MalfunctionMar 11, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CUSTOMER FACILITY CALLED TO REPORT LEAKAGE WITH THE EXT SET W/ CARE SITE & FILTER. REPORTED THAT THE PATIENT WAS HOOKED UP TO A BAG ON THURSDAY ON (B)(6) 2024 WHICH ADMINISTERING CHEMOTHERAPY. RETURNED TO THE HOSPITAL ON FRIDAY AND WHEN THE NURSE WENT TO REMOVE THE TEGADERM DRESSING AND GAUZE (AS THEY WERE STILL INFUSING THE BAG), IT WAS NOTED THE DEVICE WAS LEAKING AROUND THE FILTER AREA; NEAR THE LITTLE HOLE AROUND THE CIRCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881612 ↗
• MalfunctionJan 26, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EXT SET LEAKED DURING CHEMO USED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586403 ↗
• MalfunctionNov 6, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DESCRIPTION AS REPORTED: PER CUSTOMER, "STAFF EXPERIENCED A LEAK WHEN ADMINISTERING CHEMO." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18078600 ↗
• MalfunctionSep 19, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IV FILTER SET CHEMO SPILL. TRIPLE CHEMO (ADRIAMYCIN, VINCRISTINE, AND CYTOXAN). DETAILED INQUIRY DESCRIPTION: END USER REPORTS CHEMO SPILL WITH OUR FILTER SET. WHERE WAS THE SET LEAKING FROM SPECIFICALLY (APPEARS TO BE AIR FILTER)? LEAKING BELIEVED TO OCCUR AROUND THE 20TH (19-23RD HR) HOUR OF THE INFUSION. IN LATEST INFUSION, THEY GAVE OVER 12HRS INSTEAD OF 24HRS AND NO LEAKING OCCURRED. AIR VENT ON FLAT SIDE OF FILTER, NOT THE "HOUSE" SIDE. LEAKING OCCURRED WITH THE SAME PATIENT EVERY TIME. THE SAME MEDICATION INFUSION WAS GIVEN TO OTHER PATIENTS IN THE SAME TIME FRAME WITH NO LEAKING. WE USE B. BRAUN PUMPS AND THERE WERE NO REPORTED ALARMS DURING THE INFUSION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772375 ↗
• MalfunctionSep 19, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: IV FILTER SET CHEMO SPILL. TRIPLE CHEMO (ADRIAMYCIN, VINCRISTINE, AND CYTOXAN) DETAILED INQUIRY DESCRIPTION: END USER REPORTS CHEMO SPILL WITH OUR FILTER SET. WHERE WAS THE SET LEAKING FROM SPECIFICALLY (APPEARS TO BE AIR FILTER)? LEAKING BELIEVED TO OCCUR AROUND THE 20TH (19-23RD HR) HOUR OF THE INFUSION. IN LATEST INFUSION, THEY GAVE OVER 12HRS INSTEAD OF 24HRS AND NO LEAKING OCCURRED. AIR VENT ON FLAT SIDE OF FILTER, NOT THE "HOUSE" SIDE. LEAKING OCCURRED WITH THE SAME PATIENT EVERY TIME. THE SAME MEDICATION INFUSION WAS GIVEN TO OTHER PATIENTS IN THE SAME TIME FRAME WITH NO LEAKING. WE USE B. BRAUN PUMPS AND THERE WERE NO REPORTED ALARMS DURING THE INFUSION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772361 ↗
• MalfunctionJul 30, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THE TUBING AND FILTER SET LEAKED AND CONTAINED CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421649 ↗
• MalfunctionJul 30, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THE TUBING AND FILTER SET LEAKED AND CONTAINED CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421648 ↗
• MalfunctionJul 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING AND FILTER SET LEAKED AND CONTAINED CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421586 ↗
• MalfunctionJul 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING AND FILTER SET LEAKED AND CONTAINED CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421585 ↗
• MalfunctionJul 26, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: FLUID LEAKING AT THE DOT ON THE FILTER HOUSING THAT IS PROXIMAL TO THE PATIENT. THE TUBING AND BAG WAS DISCARDED AS CHEMO WASTE AND ANOTHER BAG OF CHEMO AND NEW TUBING WAS PREPARED TO EXCHANGE THE TUBING WITH THE LEAKING FILTER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395820 ↗
• MalfunctionJul 26, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS LEAKING IV TUBING FILTER. THE ITEM HAD A VERY EXPENSIVE AND IMPORTANT MONOCLONAL INFUSING, BLINATUMOMAB, THAT REQUIRES CONSISTENT ADMINISTRATION AT 10 ML/HR. THE TUBING (AND FILTER) IS CHANGED EVERY 24 HOURS, TO ACCOMMODATE THE CONSISTENT ADMINISTRATION OF THIS MEDICATION OVER THE COURSE OF SEVERAL WEEKS. THE FILTER SET APPEARED TO BE LEAKING AT THE FILTER SITE SEVERAL HOURS AFTER THE START OF THE NEW BAG, BUT THE NURSE WAS NOT ABLE TO DISCERN THE EXACT LOCATION OF THE LEAK. THE FILTER PART OF THE TUBING KEPT GETTING WET, SO THE IV SET HAD TO BE CHANGED WITH THE CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395730 ↗