ICU Medical CH2000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00840619033903), received between Nov 12, 2019 and Sep 18, 2026 — classified as 1 injury, 35 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Fluid/Blood Leak

  The event involved a Spinning Spiros, Closed Male Luer reported that Patient's tubing and spiros became disconnected. Spiros does not appear to be damaged. Upon arrival to unit, blood cultures drawn, new bag and tubing primed and reconnected to patient. Patient required 20ml NS flush to get blood return for blood cultures. staff attempted different methods to get blood return prior to flushing with no success. Spinning spiros and tubing of blina Double bagged, saved with cytotoxic sticker. The event occurred during infusion. There was a patient involvement but no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817937 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419825 ↗
• MalfunctionAug 17, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268798 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211527 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH REPORT NUMBER (B)(4) WAS RECEIVED WITH REGARDS TO A SPINNING SPIROS® CLOSED MALE LUER, RED CAP. IT WAS REPORTED THAT UPON CONNECTING THE SPRIOS TO THE SECONDARY ON THE PRIMARY PLUM SET, TAXOL BEGAN LEAKING FROM SPIROS. SECONDARY TUBING WAS CLAMPED, AND THE PATIENT DID NOT RECEIVE THE DOSE OF CHEMOTHERAPY. THERE WAS NO REPORTED PATIENT HARM. THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN DECEMBER 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273819 ↗
• MalfunctionDec 9, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE CUSTOMER REPORTED AN ACCIDENTAL DISCONNECTION OF A SPINNING SPIROS®, CLOSED MALE LUER FROM A PRIMARY PLUM SET (REF 14007) DURING PATIENT USE.THIS EVENT TOOK PLACE TWO WEEKS PRIOR TO THE COMPLAINT WAS RECEIVED AND THE PROBLEM WAS DETECTED DURING THE EARLY MORNING, AFTER THE PATIENT WENT TO THE BATHROOM AND RETURNED TO THEIR BED. AT THAT MOMENT, THE PATIENT CALLED FOR NURSING ASSISTANCE BECAUSE THEY FELT WET. THE NURSE RESPONDED IMMEDIATELY AND NOTICED THAT THE DISCONNECTION. UPON QUESTIONING THE PATIENT, THEY REPORTED NOT FEELING ANY ENTANGLEMENT OR TRACTION FROM THE DEVICE. THE SPIROS CONNECTION WAS DIRECTLY ATTACHED TO A BIFURCATED EXTENSION # 3312 FROM ICU MEDICAL, THROUGH WHICH SALINE SOLUTION WAS BEING INFUSED WITH A MIDLINE. THERE WAS NO DECOMPENSATION OR HARM TO THE PATIENT, AND NO TREATMENT OR BLOOD TRANSFUSION WAS REQUIRED. IT WAS ALSO REPORTED THAT THE PRODUCT WAS CONTAMINATED WITH BLOOD AND CHEMOTHERAPY DRUGS. IT WAS CONFIRMED THAT THERE WAS NO CONTACT WITH CHEMOTHERAPY SINCE THE LINE THE SPIROS HAD DISCONNECTED FROM WAS A PRIMARY INFUSION LINE THAT WAS CONNECTED DIRECTLY TO THE PATIENT'S VASCULAR ACCESS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23760604 ↗
• MalfunctionOct 30, 2025Disconnection; Disconnection

  EVENT OCCURRED REGARDING A PRODUCT DESCRIPTION OF THE SPIROS. IT WAS REPORTER THAT THREE PATIENTS WERE SENT HOME WITH A SPIROS AT THE END OF THEIR BLINATUMOMAB TUBING, AND THERE HAVE BEEN DISCONNECTIONS. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426501 ↗
• MalfunctionOct 30, 2025Disconnection; Disconnection

  EVENT OCCURRED REGARDING A PRODUCT DESCRIPTION OF THE SPIROS. IT WAS REPORTER THAT THREE PATIENTS WERE SENT HOME WITH A SPIROS AT THE END OF THEIR BLINATUMOMAB TUBING, AND THERE HAVE BEEN DISCONNECTIONS. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426483 ↗
• MalfunctionOct 30, 2025Disconnection; Disconnection

  EVENT OCCURRED REGARDING A PRODUCT DESCRIPTION OF THE SPIROS. IT WAS REPORTER THAT THREE PATIENTS WERE SENT HOME WITH A SPIROS AT THE END OF THEIR BLINATUMOMAB TUBING, AND THERE HAVE BEEN DISCONNECTIONS. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426331 ↗
• MalfunctionOct 23, 2025Disconnection; Disconnection

  A SPINNING SPIROS®, CLOSED MALE LUER REPORTEDLY DISCONNECTED FROM THE TUBING AT POINT OF CONNECTION DURING A PATIENT'S INFUSION OF MEDICATION (CYCLOPHOSPHAMIDE, TEPOTECAN, AND VINCRISTINE). THERE WAS NO HARM AND THERE WAS AN UNSPECIFIED DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375618 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SPINNING SPIROS¿, CLOSED MALE LUER GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT A FLUOROURACIL BOTTLE THAT WAS PREPARED AND SENT TO THE ONCOLOGY CLINIC FROM THE ONCOLOGY PHARMACY WAS FOUND TO BE LEAKING FROM THE CLOSED MALE LUER. A 67-YEAR-OLD PATIENT'S CHEMOTHERAPY ADMINISTRATION WAS DELAYED WHILE A NEW THERAPY WAS PREPARED AND TRANSPORTED TO THE CLINIC. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884082 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS¿, CLOSED MALE LUER WHERE IT WAS REPORTED A FLUOROURACIL BOTTLE THAT WAS PREPARED AND SENT TO THE ONCOLOGY CLINIC FROM THE ONCOLOGY PHARMACY WAS FOUND TO BE LEAKING FROM THE CLOSED MALE LUER. A 51-YEAR-OLD PATIENT'S CHEMOTHERAPY ADMINISTRATION WAS DELAYED WHILE A NEW THERAPEUTIC WAS PREPARED AND TRANSPORTED TO THE CLINIC. THE EVENT OCCURRED ON (B)(6) 2025 DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN THERAPY. THE HEALTH CARE TEAM IDENTIFIED TWO INCIDENTS FOR REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883699 ↗
• MalfunctionMay 15, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A SPINNING SPIROS¿, CLOSED MALE LUER WHERE IT WAS REPORTED THAT WHEN THE NURSE (RN) WENT TO HANG A NEW BAG OF IV NORMAL SALINE, THE RN SAW BLOOD BACK FLOWING INTO PRIMARY AND Y-SITED IV TUBING. THE RN NOTICED THAT THE SPIROS WAS NOT ENGAGED FULLY WITH CHEMO TUBING. ANOTHER RN ATTEMPTED TO ENGAGE SPIROS FULLY. IT APPEARED INTACT, BUT AFTER A FEW MINUTES IT BECAME DISCONNECTED AGAIN AND SPIROS WAS REPLACED, AND THE CONNECTION APPEARED TO BE WORKING PROPERLY. THE DRUG INVOLVED WAS CYTARABINE. THERE WAS PATIENT INVOLVEMENT AND ONLY A FEW MINUTES DELAY IN THERAPY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031864 ↗
• MalfunctionMay 14, 2025Disconnection; Disconnection

  THE EVENT INVOLVED A SPINNING SPIROS¿, CLOSED MALE LUER WHERE IT WAS REPORTED THAT WHEN THE PATIENT WAS BEING CONNECTED TO CHEMOTHERAPY, IT POPPED OFF RIGHT BEFORE CHEMO STARTED. THEY WOULD NOT REATTACH TO TUBING AND SPIROS CHANGED AT THAT TIME. THE DRUG INVOLVED WAS A NORMAL SALINE. THE PRIMARY TUBING WAS NOT ATTACHED AND SEQUESTERED AFTER CHEMOTHERAPY INFUSION (VINCRISTINE) AND RETURNED TO THEM. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND A FEW MINUTES OF DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021304 ↗
• MalfunctionMar 14, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A SPINNING SPIROS¿, CLOSED MALE LUER THAT EXPERIENCED BREAKAGE AND LEAKAGE. THE REPORTER STATED THAT THE SPINNING SPIROS CLOSED MALE LUER WAS FOUND TO HAVE A TORN/CUT/BROKEN ON THE BLUE ELASTIC PART. THEY HAVE SEEN 7 OCCURRENCES OF LEAKING SPIROS SO FAR. THE EVENT DATE WAS UNKNOWN. SAMPLE PHOTO SHOWING THE DEFECTIVE PRODUCT WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21611786 ↗
• MalfunctionMar 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A SPINNING SPIROS¿, CLOSED MALE LUER WAS FOUND TO HAVE BECOME DETACHED DURING PATIENT USE. THE PROBLEM WAS: THAT SOME SPIROS PRODUCT CODE: CH2000S SEEMED TO BE DETACHING FROM THEIR 50ML SYRINGES WHEN UTILIZED FOR INTRAVESICAL TREATMENTS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21530816 ↗
• MalfunctionFeb 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN DECEMBER OF 2024 INVOLVING AN UNSPECIFIED SPINNING SPIROS. THE CUSTOMER REPORTED THAT, ¿TAXOL CHEMOTHERAPY WAS HUNG ON THE PRIMARY INTRAVENOUS (IV) SET WITH A SPINNING SPIROS CONNECTION FROM THE SECONDARY TUBING PLACED AND MADE IN THE PHARMACY. AFTER THE PUMP STARTED AT A RATE OF APPROXIMATELY 200 MILLILITERS PER HOUR THE REGISTERED NURSE (RN) WALKED AWAY BUT AFTER A FEW MINUTES CAME BACK TO AN ALARMING PUMP. THE TAXOL WAS LEAKING FROM THE SPINNING SPIROS CONNECTION. THE SECONDARY TUBING WAS CLAMPED AND THE PUMPED STOPPED. THE SPILL OF APPROXIMATELY 20 MILLILITERS WAS CLEANED PER CHEMOTHERAPY SPILL PROTOCOL BY THE CHARGE RN. MEDICATION DID NOT TOUCH PATIENT OR RN DURING LEAKAGE. THE DEFECTIVE DEVICE WAS REPLACED AND THERAPY RESUMED. NO HOLE, CUT, TEARS, LOOSE CONNECTIONS, OR ANY DEFECTS NOTED. THE DEVICE HAS BEEN DISCARDED DUE TO CHEMO CONTAMINATION. THE CUSTOMER STATED THAT "CHEMO SET UP (TUBING AND SPIROS) DELIVERED FROM PHARMACY- PER PHARMACY- THEY USE THE REF# CL 3011 30¿ 20 DROP APPROX ADMIN SET W/ INTEGRATED CHEMOLOCK DROP CHAMBER, SPRIOS W/ RED CAP HANGER. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433799 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A SPINNING SPIROS¿, CLOSED MALE LUER WHERE IT WAS REPORTED THAT AN 84-YEAR-OLD OUTPATIENT WAS RECEIVING CHEMOTHERAPY VIA BLADDER INSTALLATION. WHEN THE NURSE ATTEMPTED TO ADMINISTER THE CHEMOTHERAPEUTIC AGENT, THE CONNECTOR AT THE END OF THE SYRINGE CAME OFF AND 1 TO 2 MILLILITERS OF CHEMOTHERAPY SPILLED ONTO THE BED. THE LOCATION WAS CLEANED WITH BLUE PADS, WATER, SOAP, AND BLEACH. THE PATIENT REPORTED THAT NOTHING TOUCHED THE PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376651 ↗
• InjuryFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS®, CLOSED MALE LUER. THE CUSTOMER REPORTED THAT A PATIENT HAD CHEMOTHERAPY MEDICATION (UNSPECIFIED) INFUSING AND WAS SLEEPING AND WHEN HE TURNED IN THE BED, HIS ELBOW LANDED ON TOP OF THE SPIROS CAUSING IT TO SHATTER. THE PATIENT RECEIVED A CUT AND WAS BLEEDING FROM THE SPIROS WHEN IT SHATTERED. THE CHEMO LEAKED ONTO THE BED AND FLOOR. THE PRODUCT WAS PLACED IN THE CYTOTOXIC BIN AFTER THE INCIDENT. THERE WAS PATIENT INVOLVEMENT, BUT NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360888 ↗
• MalfunctionNov 8, 2024Disconnection; Disconnection

  ADDITIONAL INFORMATION RECEIVED ON16-DEC-2024 STATING THAT THIS COMPLAINT WAS ORIGINALLY REPORTED BY A HOME PATIENT AND NO MORE INFORMATION CAN BE GATHERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641201 ↗
• MalfunctionAug 7, 2024Crack; Disconnection; Separation Problem; Crack; Disconnection; Separation Problem

  THE CUSTOMER RETURNED TWO ADDITIONAL DEVICES UNDER FOR EVALUATION UNDER 9617594-2024-00766-01. THE DATE OF EVENT IS UNKNOWN. THE ORIGINAL REPORTED CONDITION CRACK/DISCONNECTION/SEPARATION WAS CONFIRMED DURING EVALUATION FOR THE TWO ADDITIONAL RETURNED COMPLAINTS. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928527 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS¿, CLOSED MALE LUER WHERE IT WAS REPORTED THAT THE SPIROS IS ATTACHED TO THE FILTERED EXTENSION SET. CUSTOMER HEARS THE CRACK, CONFIRMING THAT THE SPIROS SHOULD BE BONDED TO THE TUBING. AFTER HEARING THE CRACK WHEN ATTACHING THE SPIROS TO THE TUBING, THE CUSTOMER CAN EASILY REMOVE THE SPIROS OR IT COMES DISCONNECTED ITSELF. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE END USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813245 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS®, CLOSED MALE LUER WHERE THE CUSTOMER REPORTED THAT DURING THE MANIPULATION OF THE CHEMOTHERAPY MEDICATION, THE SPIROS CONNECTER WAS PLACED IN THE TIP OF THE SET, WITH A TRIPLE CHECK OF THE MATERIAL'S LOCK. AFTER 1H50MIN OF INFUSION, THE SET CAME LOOSE FROM THE SPIROS AND THE MEDICATION LEAKED OUT. THE EVENT OCCUR DURING PATIENT USE AND NO ONE WAS REPORTED HARMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767323 ↗
• MalfunctionJun 23, 2024Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS¿, CLOSED MALE LUER WHERE IT WAS REPORTED THAT THE SPIROS IS ATTACHED TO THE FILTERED EXTENSION SET. CUSTOMER HEARS THE CRACK, CONFIRMING THAT THE SPIROS SHOULD BE BONDED TO THE TUBING. AFTER HEARING THE CRACK WHEN ATTACHING THE SPIROS TO THE TUBING, THE CUSTOMER CAN EASILY REMOVE THE SPIROS OR IT COMES DISCONNECTED ITSELF. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE END USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591725 ↗
• MalfunctionJun 21, 2024Disconnection; Disconnection

  THE EVENT OCCURRED ON 5/12/2024 AND 5/19/2024 INVOLVING A SPINNING SPIROS®, CLOSED MALE LUER. IT WAS REPORTED THAT THEY HAD TWO INCIDENTS OF A SPIROS CAP DISCONNECTING WITH BLINATUMOMAB INFUSING. IT DISCONNECTED ON THE PATIENT END OF THE SPIROS. THEY DO NOT HAVE THE LOT NUMBER FOR ANY OF THE PRODUCTS AND STAFF ONLY SAVED ONE SPIROS. THE PATIENT'S LINE BECAME DISCONNECTED 3 TIMES DURING THE WEEK OF 5/12-5-18 CAUSING 3 BAGS OF IMMUNOTHERAPY TO SPILL AND BE WASTED. PATIENTS RECEIVED A FULL DOSE OF THERAPY WITH NO SIGNS OF INFECTION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585104 ↗