ICU Medical 011-CS-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619005955), received between Oct 14, 2020 and Apr 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE THAT EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿THE REPORTER STATED THAT DURING THE PREPARATION OF A BAG OF PACLITAXEL LOT: 2513IK1 AND EXPIRY: 01/04/2025, AFTER ATTACHING THE SPIKE IN QUESTION THERE WAS A LOSS OF CTA FROM THE SPIKE, NOT AT THE POINT OF ENGAGEMENT, BUT IN THE LOWER PART. THERE WAS NO PATIENT HARM. THE ACTUAL SAMPLE IS NOT AVAILABLE, SAMPLE VIDEOS WERE PROVIDED.¿ IN CLARIFICATION TO THE ABOVE ENTRY, THERE WAS A LEAK NOTICED FROM THE SPIKE. THERE WAS NO BLOOD LOSS. THE PATIENT WAS INVOLVED; HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936411 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE WHERE IT WAS REPORTED THAT A SPILLAGE OF 5-FLUOROURACIL (5-FU) TO THE DETRIMENT OF THE HEALTHCARE WORKER C.C. DUE TO A FAILURE OF THE CLAVE CONNECTOR DEVICE TO SEAL. THERE WAS NO PATIENT INVOLVEMENT, IT OCCURRED DURING THE PREPARATION OF THE CHEMOTHERAPY PRODUCT. THERE WAS NO HUMAN HARM, NO CLINICAL CONSEQUENCES EXCEPT THE FACT THAT THE PREPARATOR REPORTED A SLIGHT REDNESS IN THE AREA OF CONTACT WITH THE CHEMOTHERAPY AND HE VISITED EMERGENCY DEPARTMENT, NO DEATH, NO BLOOD LOSS, NO DELAY IN CRITICAL THERAPY AND NO MEDICAL INTERVENTION. THE HEALTH CONDITION OF THE PREPARATOR BEFORE AND AFTER THE EVENT DID NOT CHANGE. THE PROBLEM OCCURRED DURING PREPARATION. THE CHEMO CAME INTO CONTACT WITH THE OPERATOR'S LEFT HAND. THE SPILL WAS CLEANED UP PER PROTOCOL, BUT A SPILL KIT WAS NOT USED. THE MANUFACTURER OF THE SOLUTION CONTAINER IS BAXTER. THE BAG CONTAINING 5-FU WAS DISPOSED OF AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379444 ↗
• MalfunctionOct 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE THAT LEAKED CYCLOPHOSPHAMIDE. IT WAS REPORTED THAT DURING INFUSION, A SOLUTION CONTAINER OF CYCLOPHOSPHAMIDE WAS FOUND TO BE LEAKING FROM THE CLAVE ATTACHMENT WHEN IT WAS HUNG. THERE WAS NO LEAK OBSERVED WHEN UNPACKING THE CONTAINER AND THERE WAS NO OBSERVABLE DAMAGE TO THE CLAVE ATTACHMENT. THE PATIENT WAS SITTING, WAITING FOR TREATMENT. THERE WAS PATIENT INVOLVEMENT, NO SKIN CONTACT WITH THE CYTOTOXIC SOLUTION BY THE PATIENT OR NURSING STAFF, NO REPORT OF PATIENT HARM OR INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT, HOWEVER ONE OF THE NURSES REPORTED HAVING A HEADACHE AFTER THE PRODUCT LEAKED. THE HEADACHE WAS TEMPORARY AND RESOLVED AFTER THE CONTAINER WAS DISCARDED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10679171 ↗