ICU Medical CH2000S-PCRecalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00840619027568), received between Oct 23, 2018 and Sep 16, 2025 — classified as 83 malfunctions.

The most frequently reported specific device problem is “Disconnection” (45 reports).

5 other recalls cover devices cleared under the same FDA submission (K082806); 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. 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025No Flow; No Flow

  EVENT OCCURRED REGARDING A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE THE REPORTER STATED, ¿CAUSING DOWNSTREAM OCCLUSION WHEN CONNECTED." THERE WAS PATIENT INVOLVEMENT AND DELAY IN THERAPY. THERE WAS NO HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069338 ↗
• MalfunctionMay 16, 2025No Flow; No Flow

  THE EVENT OCCURRED BETWEEN (B)(6) 2025 INVOLVING A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE IT WAS REPORTED THAT ANOTHER PATIENT WAS AFFECTED WITH AN ISSUE OF 2 METHOTREXATE SYRINGES NOT BEING ABLE TO BE ADMINISTERED DUE TO STUCK PLUNGER. THE CUSTOMER REPORTED ANOTHER PATIENT (RC) RECEIVING 25MG METHOTREXATE WITH SPIROS WITH THE SAME REPORTED ISSUE OF THE PLUNGER OF THE SYRINGE NOT BUDGING, NOTING 4 OUT OF 6 SYRINGES WORKED. CUSTOMER REPORTED THEY "REMOVED THE NEEDLE FROM THEIR TUMMY AND TRIED TO PUSH IT THROUGH THE NEEDLE BUT NOTHING, SO THEY ALSO REMOVED THE NEEDLE FROM THE SYRINGE AND TRIED, AGAIN NOTHING COMING OUT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT TRIED TO WARM IT UP TO SEE IF THAT WOULD WORK AND AGAIN NOTHING. THE CUSTOMER ADVISED THAT "EVERYTHING LOOKED GOOD EXCEPT THE PLUNGER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040713 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED AN UNSPECIFIED SPINNING SPIROS® DEVICE. LEAKS WERE REPORTED AT THE PORT OF AN UNSPECIFIED SPINNING SPIRO, NON-RETURN VALVE (=K ZERO ADAPTER). THE LEAKAGE WAS IN THE AREA WHERE THE CONNECTION VALVE WAS USED. THESE WERE THE FOLLOWING NEGATIVE EFFECTS THAT WERE REPORTED: 1. UNCLEAR QUANTITY OF CYTOSTATICS ACTUALLY INFUSED. 2. SKIN IRRITATION DUE TO LEAKING CYTOSTATICS. 3. STRESSFUL SITUATION FOR THE PATIENT (PSYCHOLOGICAL COMPONENT). 4. DANGER TO THIRD PARTIES DUE TO THE UNCONTROLLED RELEASE OF CYTOSTATIC DRUGS. PRODUCT DETAILS ARE AS FOLLOW: 1. K-ZERO ADAPTER REF M79400849Y, LOT 32221354. 2. POWERLOC MAXPORT NEEDLE: SIZE 19 GX0.75, REF 0141975, LOT ASGXFC055. 3. SPINNING SPIRO (DOC SID 4000 OR DOC SID 4000 R) 4. ELASTOMER PUMP. THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: Anxiety; Chemical Exposure; Skin Inflammation/ Irritation

  MAUDE report 21905407 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED AN UNSPECIFIED SPINNING SPIROS WHERE IT WAS REPORTED THAT IT LEAKS AT PORT, SPINNING SPIRO, NON-RETURN VALVE (=K ZERO ADAPTER) IN CONNECTION WITH ELASTOMER PUMP. THE PROBLEM WAS THE FLUID LEAKAGE IN THE AREA OF THE CONNECTION VALVES USED. THESE ARE THE FOLLOWING NEGATIVE EFFECTS: 1. UNCLEAR QUANTITY OF CYTOSTATIC ACTUALLY INFUSED. 2. SKIN IRRITATION DUE TO LEAKING CYTOSTATIC. 3. STRESSFUL SITUATION FOR THE PATIENT (PSYCHOLOGICAL COMPONENT). 4. DANGER TO THIRD PARTIES DUE TO THE UNCONTROLLED RELEASE OF CYTOSTATIC DRUGS. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation

  MAUDE report 21773394 ↗
• MalfunctionMar 21, 2025No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A SPINNING SPIROS CLOSED MALE LUER, PURPLE CAP THAT EXPERIENCED NO FLOW UPON MEDICATION DRAW. THE METHOTREXATE SYRINGE REPORTEDLY COULD NOT BE PUSHED OR ADMINISTERED BY THE PATIENT DUE TO A STUCK PLUNGER ON THE DEVICE. THIS OCCURRED DURING PREPARATION FOR ADMINISTRATION. THE CUSTOMER ADVISED THAT THE PATIENT WAS GOING TO TRY AGAIN LATER THAT NIGHT. THIS PATIENT HAS BEEN USING THE METHOTREXATE SYRINGE FROM BAXTER FOR 8 YEARS AND THIS IS THE FIRST ISSUE THEY HAVE ENCOUNTERED. THE PATIENT MENTIONED THAT THEY HAD TO FIDDLE AROUND WITH THE NEEDLE A LITTLE BIT TO GET IT TO SIT ON THE SYRINGE. IT WAS CONFIRMED THAT PRODUCT PACKAGING CAME IN GOOD CONDITION AS PER USUAL. THERE WAS NO MEDICAL INTERVENTION WAS REQUIRED AND NO INJURY WAS REPORTED TO BE ASSOCIATED WITH THE EVENT. THERE WERE 4 UNITS ASSOCIATED WITH THIS REPORTED COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661033 ↗
• MalfunctionMar 21, 2025No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A SPINNING SPIROS CLOSED MALE LUER, PURPLE CAP THAT EXPERIENCED NO FLOW UPON MEDICATION DRAW. THIS IS REPORT 2 OF 2. THE METHOTREXATE SYRINGE REPORTEDLY COULD NOT BE PUSHED OR ADMINISTERED BY THE PATIENT DUE TO A STUCK PLUNGER ON THE DEVICE. THIS OCCURRED DURING PREPARATION FOR ADMINISTRATION. THE CUSTOMER ADVISED THAT THE PATIENT WAS GOING TO TRY AGAIN LATER THAT NIGHT. THIS PATIENT HAS BEEN USING THE METHOTREXATE SYRINGE FROM BAXTER FOR 8 YEARS AND THIS IS THE FIRST ISSUE THEY HAVE ENCOUNTERED. THE PATIENT MENTIONED THAT THEY HAD TO FIDDLE AROUND WITH THE NEEDLE A LITTLE BIT TO GET IT TO SIT ON THE SYRINGE. IT WAS CONFIRMED THAT PRODUCT PACKAGING CAME IN GOOD CONDITION AS PER USUAL. THERE WAS NO MEDICAL INTERVENTION WAS REQUIRED AND NO INJURY WAS REPORTED TO BE ASSOCIATED WITH THE EVENT. THERE WERE 6 UNITS ASSOCIATED WITH THIS REPORTED COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660852 ↗
• MalfunctionMar 21, 2025No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A SPINNING SPIROS CLOSED MALE LUER, PURPLE CAP THAT EXPERIENCED NO FLOW UPON MEDICATION DRAW. THIS IS REPORT 1 OF 2. THE METHOTREXATE SYRINGE REPORTEDLY COULD NOT BE PUSHED OR ADMINISTERED BY THE PATIENT DUE TO A STUCK PLUNGER ON THE DEVICE. THIS OCCURRED DURING PREPARATION FOR ADMINISTRATION. THE CUSTOMER ADVISED THAT THE PATIENT WAS GOING TO TRY AGAIN LATER THAT NIGHT. THIS PATIENT HAS BEEN USING THE METHOTREXATE SYRINGE FROM BAXTER FOR 8 YEARS AND THIS IS THE FIRST ISSUE THEY HAVE ENCOUNTERED. THE PATIENT MENTIONED THAT THEY HAD TO FIDDLE AROUND WITH THE NEEDLE A LITTLE BIT TO GET IT TO SIT ON THE SYRINGE. IT WAS CONFIRMED THAT PRODUCT PACKAGING CAME IN GOOD CONDITION AS PER USUAL. THERE WAS NO MEDICAL INTERVENTION WAS REQUIRED AND NO INJURY WAS REPORTED TO BE ASSOCIATED WITH THE EVENT. THERE WERE 6 UNITS ASSOCIATED WITH THIS REPORTED COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660671 ↗
• MalfunctionDec 27, 2024Material Separation; Material Separation

  IT WAS STATED THAT UNSPECIFIED SPIROS EXPERIENCED DISCONNECTION. IT WAS STATED THAT "AS WE DISCUSSED WE HAVE HAD NUMEROUS ISSUES WITH SPIROS DISCONNECTING FROM THE REST OF THE GIVING SET ¿ THIS HAS OCCURRED FROM ALL POTENTIAL PARTS OF THE SET BUT IN PARTICULAR FROM Y CONNECTORS. SO FAR, THIS HAS ALWAYS BEEN FROM THE SIDE WHERE THE PURPLE CAP IS. THIS HAS BEEN ENCOUNTERED WHEN ATTACHED TO PATIENTS WITH CHEMOTHERAPY RUNNING. WHEN INVESTIGATING, GRACE AND I HAVE FOUND THE SPIROS TO DISCONNECT FROM THE Y-CONNECTOR WHEN WE ARE HOLDING IT IN OUR HANDS." THE EVENT OCCURRED DURING CHEMOTHERAPY RUNNING. THE HANDLING / USE OF THE PRODUCT OF THE EVENT OCCUR WAS DURING USE ON PATIENT. OTHER PRODUCTS INVOLVED AT THE TIME OF EVENT WAS THE BIFURCATED MINIBORE EXTENSION SET WHERE THE MANUFACTURER WAS CODAN. SOMEONE BECOME AWARE OF THE ISSUE WHEN TUBING NOTED TO BE DISCONNECTED WITH PATIENT TREATMENT, ALSO NOTED WHEN BEING PRIMED FOR ADMINISTRATION. THERE WAS MEDICATION BEING USED WITH THIS PRODUCT AND IT WAS CHEMOTHERAPY. STATED THAT THEY HAVE A SAMPLE THAT WAS USED IN THE VIDEOS, AND IT WAS NOT CONTAMINATED. THERE ARE 2 VIDEOS SHOWING THE SPIRO UNSCREWING BY THERE WAS PATIENT INVOLVEMENT BUT NO A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030552 ↗
• MalfunctionOct 1, 2024Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP. THE CUSTOMER REPORTED THAT THE DEVICE DISCONNECTED/SEPARATED AND THEN LEAKED DURING PATIENT INFUSION OF METHOTREXATE. THE EXACT LOCATION OF THE LEAKAGE WAS FROM WHERE THE SPIROS DISCONNECTED FROM THE LINE AND THE CHEMO LEAKED OUT OF THE GIVING SET. THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL; SPILLS WERE ALWAYS CLEANED AS PER LOCAL POLICY USING A SPILL KIT. INTERVENTIONS RELATING TO PATIENT INCLUDED CHANGING LINES AND MAKING A PLAN FOR LOST CHEMOTHERAPY. WHEN ASKED IF THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM, THE CUSTOMER STATED THAT IT DEPENDED ON THE CHEMOTHERAPY AND SITUATION; IF POSSIBLE, DIFFERENT LINES WERE USED HOWEVER THIS WAS OFTEN NOT FEASIBLE DUE TO LOSS OF CHEMOTHERAPY IN THE LINE ITSELF SO IT HAD TO BE CLEANED AND RECONNECTED WHICH GOES AGAINST RECOMMENDED BEST PRACTICE FOR CENTRAL LINE CARES AND INFECTION PREVENTION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347521 ↗
• MalfunctionOct 1, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE THE CUSTOMER REPORTED THAT THE DEVICE SEPARATED/DISCONNECTED FROM THE LINE ¿ CHEMO (GANCICLOVIR) LEAKS OUT OF THE GIVING SET DURING PATIENT USE. THE REPORTER MENTIONED THAT THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE SET THAT CAUSED THE SEPARATION/DISCONNECTION. THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL. SPILLS ARE ALWAYS CLEANED AS PER LOCAL POLICY USING A SPILL KIT. INTERVENTIONS RELATING TO PATIENT INCLUDED CHANGING LINES AND MAKING A PLAN FOR LOST CHEMOTHERAPY. WHEN ASKED IF THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM, THE CUSTOMER RESPONDED THAT IT DEPENDS ON THE CHEMOTHERAPY AND SITUATION, AND WHEN POSSIBLE, DIFFERENT LINES ARE USED HOWEVER THIS WAS OFTEN NOT FEASIBLE DUE TO LOSS OF CHEMOTHERAPY IN THE LINE ITSELF SO IT HAD TO BE CLEANED AND RECONNECTED WHICH GOES AGAINST RECOMMENDED BEST PRACTICE FOR CENTRAL LINE CARES AND INFECTION PREVENTION. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346517 ↗
• MalfunctionSep 30, 2024Disconnection; Fluid/Blood Leak; Separation Problem; Disconnection; Fluid/Blood Leak; Separation Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE THE CUSTOMER REPORTED THAT THE DEVICE DISCONNECTED DURING PATIENT USE. THE REPORTER STATED THAT THERE WAS NO VISIBLE DAMAGED ON THE SET THAT CAUSED THE DISCONNECTION. THE EXACT LOCATION OF THE LEAKAGE WAS FROM WHERE THE SPIROS DISCONNECTED FROM THE LINE AND CHEMO LEAKS OUT OF THE GIVING SET WHILE ADMINISTERING IFOSFAMIDE. THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL, HOWEVER, SPILLS ARE ALWAYS CLEANED AS PER LOCAL POLICY USING A SPILL KIT. INTERVENTIONS RELATING TO PATIENT INCLUDED CHANGING LINES AND MAKING A PLAN FOR LOST CHEMOTHERAPY. THERE WAS A DELAY IN THERAPY. WHEN ASKED IF THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM, THE CUSTOMER RESPONDED THAT IT DEPENDS ON THE CHEMOTHERAPY AND SITUATION. WHEN POSSIBLE, DIFFERENT LINES ARE USED HOWEVER THIS IS OFTEN NOT FEASIBLE DUE TO LOSS OF CHEMOTHERAPY IN THE LINE ITSELF SO IT HAD TO BE CLEANED AND RECONNECTED WHICH GOES AGAINST RECOMMENDED BEST PRACTICE FOR CENTRAL LINE CARES AND INFECTION PREVENTION. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339800 ↗
• MalfunctionSep 30, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE THE CUSTOMER REPORTED THAT SEVERAL TIMES (UNSPECIFIED QUANTITY) THE SPIROS BECAME DISCONNECTED DURING PATIENT AFTER A FEW MINUTES USE WITH CHEMOTHERAPY (DINUTUXIMAB) IN PEDIATRICS. SOMEONE BECAME AWARE OF THE EVENT DUE TO LEAKAGE IN THE BED AND NOTICED A LOOSE CONNECTION. THE CUSTOMER STATED THAT THERE WAS NO VISIBLE DAMAGED ON THE SET THAT CAUSED THE DISCONNECTION. THE EXACT LOCATION OF THE LEAKAGE WAS FROM WHERE THE SPIROS DISCONNECTED FROM THE LINE AND CHEMO LEAKS OUT OF THE GIVING SET. THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL, HOWEVER, THE SPILLS ARE ALWAYS CLEANED AS PER LOCAL POLICY USING A SPILL KIT. INTERVENTIONS RELATING TO PATIENT INCLUDED CHANGING LINES AND MAKING A PLAN FOR LOST CHEMOTHERAPY. THE CUSTOMER WAS ASKED IF THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM, AND THE CUSTOMER STATED THAT IT DEPENDED ON THE CHEMOTHERAPY AND SITUATION; WHEN POSSIBLE, DIFFERENT LINES WERE USED HOWEVER THIS WAS OFTEN NOT FEASIBLE DUE TO LOSS OF CHEMOTHERAPY IN THE LINE ITSELF SO IT HAD TO BE CLEANED AND RECONNECTED WHICH GOES AGAINST RECOMMEND

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334098 ↗
• MalfunctionJun 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED, ¿LEAKING BETWEEN THE SPIROS AND THE BD MAXPLUS." THE SAMPLE IS AVAILABLE. THERE WAS PATIENT INVOLVEMENT, NO DELAY IN THERAPY, NO HARM AS A RESULT OF THE REPORTED EVENT. THERE WAS NO DEATH OR SERIOUS DETERIORATION AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640499 ↗
• MalfunctionJun 18, 2024Connection Problem; Connection Problem

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE IT WAS REPORTED WHEN THE REGISTERED NURSE (RN) CONNECTED SPIROS TO MAXPLUS, THERE WERE TWO EPISODES OF SPIROS BEING PUSHED OUT BY POSITIVE PRESSURE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) BUNG. IN ONE INSTANCE YOU COULD ACTUALLY SEE THE SPIROS BEING ROTATED AND PUSHED OUT DESPITE HOW HARD IT WAS PLACED BACK. THE DRUG INVOLVED WAS PACLITAXEL. THERE WAS PATIENT INVOLVEMENT, AND A DELAY IN THERAPY BUT NO PATIENT HARM AS A RESULT OF THE REPORTED EVENT. THIS REPORT CAPTURES TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564088 ↗
• MalfunctionJun 17, 2024Leak/Splash; Leak/Splash

  ISSUE NOTICED DURING PREPARATION (FRANCE). THE LIQUID WENT INTO THE BODY OF THE SPIROS AND LEAKED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554764 ↗
• MalfunctionDec 27, 2023No Flow; No Flow

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP. THE REPORTER STATED A SPIROS CLOSED MALE CONNECTOR WAS CONNECTED TO A 5ML TERUMO SYRINGE; THE CUSTOMER EXPLAINED THAT THEY WERE UNABLE TO PUSH THE DOSE OF AZACITIDINE OUT OF THE SYRINGE THROUGH THE ATTACHMENT (SPIROS CLOSED MALE CONNECTOR (CH2000S-PC). THE PATIENT WAS IN THE SEAT, AND THE CLINICIAN WAS ATTEMPTING TO ADMINISTER THE FLUID, HOWEVER IT WAS NOT PRIMING. THERE WAS A DELAY IN THERAPY SINCE THE CLINICIAN HAD TO DISCARD AND REMAKE THE CLINICAL PROCEDURAL PACK FOR ADMINISTRATION. THE SOLUTION/MEDICATION INVOLVING AZACITIDINE POWDER FORM CHEMOTHERAPY DRUG, WITH ADDED WATER FOR INJECTION. THERE WAS APPROXIMATELY 1 HOUR DELAY. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS REPORT CAPTURES THE SECOND OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398869 ↗
• MalfunctionDec 27, 2023No Flow; No Flow

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP. THE REPORTER STATED A SPIROS CLOSED MALE CONNECTOR WAS CONNECTED TO A 5ML TERUMO SYRINGE; THE CUSTOMER EXPLAINED THAT THEY WERE UNABLE TO PUSH THE DOSE OF AZACITIDINE OUT OF THE SYRINGE THROUGH THE ATTACHMENT (SPIROS CLOSED MALE CONNECTOR (CH2000S-PC). THE PATIENT WAS IN THE SEAT, AND THE CLINICIAN WAS ATTEMPTING TO ADMINISTER THE FLUID, HOWEVER IT WAS NOT PRIMING. THERE WAS A DELAY IN THERAPY SINCE THE CLINICIAN HAD TO DISCARD AND REMAKE THE CLINICAL PROCEDURAL PACK FOR ADMINISTRATION. THE SOLUTION/MEDICATION INVOLVING AZACITIDINE POWDER FORM CHEMOTHERAPY DRUG, WITH ADDED WATER FOR INJECTION. THERE WAS APPROXIMATELY 1 HOUR DELAY. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS REPORT CAPTURES ONE OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398860 ↗
• MalfunctionDec 20, 2023Crack; No Flow; Crack; No Flow

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP WHERE IT WAS REPORTED THAT THE DEVICE CAME FROM PHARMACY SUPPLY AND WAS CRACKED. THE BROKEN TUBING WAS NOTICED WHEN SPIROS WAS CONNECTED TO Y-SITE FOR INFUSION. FLUID WOULD NOT INFUSE, BEEPED OCCLUSION. THE REP CAP WAS PLACED BY THE NURSE BECAUSE IT WAS THE MOST READILY AVAILABLE PRODUCT IN THE ROOM WHILE THE PRODUCT WAS MALFUNCTIONING. THIS WAS A SPECIAL CIRCUMSTANCE AND NOT THEIR NORMAL PRACTICE. THERE WAS PATIENT INVOLVED BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363806 ↗
• MalfunctionDec 18, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP. ON THE FOURTH DAY OF THE BIG PROTOCOL, THE HEALTHCARE ASSISTANT FROM THE SECTOR NOTIFIED THE NURSE AROUND 4 PM (7 HOURS AFTER THE START OF ADMINISTRATION, OUT OF THE 12 HOUR PERIOD) THAT THE CHEMOTHERAPY SYRINGE HAD AN AIR IN LINE ALARM AND AIR BUBBLES IN THE TUBING NEAR THE SYRINGE (CAIR) WERE IDENTIFIED. UPON ARRIVAL, THE NURSE DID NOT OBSERVE AIR BUBBLES; HOWEVER, THE SYRINGE AXIS WAS NOT STRAIGHT AND A DROP OF CHEMOTHERAPY (CYTARABINE) LEAKED FROM THE SYRINGE AT THE JUNCTION BETWEEN THE SYRINGE AND THE TUBING, A CRACK WAS OBSERVED AT THE LEVEL OF THE SECURE CONNECTION ASSEMBLED AT THE CHEMOTHERAPY PREPARATION UNIT. THE INFUSION STOPPED, AND THE SYRINGE WAS CHANGED BY EXTRACTING THE REMAINING QUANTITY OF THE CHEMOTHERAPY WITHOUT A SECURED DEVICE. CLINICAL CONSEQUENCES AND CURRENT CONDITION OF THE PATIENT OR PERSON INVOLVED: HANDLING OF CYTOTOXIC PRODUCTS BY THE HEALTHCARE PROVIDERS, POTENTIAL LOSS OF PRODUCT AND THUS EFFECTIVENESS. THE TUBING HAS BEEN TESTED BY THE CAIR MANUFACTURER: NO LEAKAGE DEFECT HAS BEEN IDENTIFIED DURING CHEMOTHERAPY ADMINISTRATION. DURING THE EVENT, THE PATIENT WAS STABLE, NO O

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352878 ↗
• MalfunctionDec 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP AND THE CUSTOMER REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) IN THE CHEMOTHERAPY DEPARTMENT OBSERVED A A SIGNIFICANT FLOW/LEAK OF PRODUCT {PHESGO MEDICATION) BETWEEN THE SYRINGE AND THE SPIROS CONNECTOR WHEN PASSING IT INTO A 10ML SYRINGE ON A SYRINGE-DRIVER. THE CUSTOMER REPORTED ABOUT A 30 MIN DELAY IN THERAPY AS THEY HAD TO REDO THE PREPARATION OF MEDICATION. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT. THE MEDICATION DID COME INTO CONTACT WITH THE HCP BUT THE STAFF WAS PROTECTED BY GLOVES AND BLOUSE. THE LEAK CLEANED PER FACILITY PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253572 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP GENERATED A LEAK. THE REPORTER STATED, ¿PHARMACIST FROM (B)(6) HOSPITAL EMAILED BAXTER COMPOUNDING SERVICES ON (B)(6) 2023 TO REPORT 1 BORTEZOMIB SYRINGE WAS LEAKING. CUSTOMER REPORTED THE SYRINGE FOR PATIENT LEAKED WHERE THE CONNECTION WITH THE SPIROS CONNECTOR IS MADE. THIS WAS REPORTED BY THE NURSES AND DRUG CAME IN TOUCH WITH THE NURSES GLOVES. CUSTOMER USED THE PRODUCT. FURTHER INFORMATION REQUESTED FROM CUSTOMER VIA QA SPECIALIST OF BAXTER COMPOUNDING SERVICES INCLUDING AT WHICH STAGE THE LEAK WAS IDENTIFIED, WHETHER ORIGIN OF THE LEAK (REPORTED AS THE CONNECTION WHERE THE SPIROS CONNECTOR IS MADE) WAS DUE TO DAMAGE TO THE SYRINGE, OR FAULTY SPIROS CONNECTOR, OR INCORRECT ATTACHMENT OF THE SPIROS CONNECTOR, WHETHER THE LEAK WAS SUBSEQUENTLY STEMMED IN ORDER FOR THE PRODUCT TO BE USED, WHETHER THERE WAS ANY STAFF / PATIENT INJURY, OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT AND WHETHER THERE WAS ANY DAMAGE OBSERVED TO THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN. THIS WAS IDENTIFIED AT THE HOSPITAL ON (B)(6) 2023 PRIOR TO USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17486114 ↗
• MalfunctionAug 3, 2023Disconnection; Disconnection

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION ON AUGUST 07, 2023: THE INCIDENT WAS OBSERVED DURING THE PREPARATION OF CYCLOPHOSPHAMIDE FOR THE PUI (HOSPITAL PHARMACY) BEFORE DISPENSING TO CARE SERVICES. NO ADVERSE EVENTS, NO HUMAN HARM, NO DELAY IN THERAPY, NO BLOOD LOSS AND NO PHYSICAL DEFECTS WERE OBSERVED BEFORE USE. NO LEAKAGE WAS NOTED. THE INCIDENT WAS OBSERVED AT THE END OF DRUG PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452987 ↗
• MalfunctionJul 27, 2023Disconnection; Disconnection

  ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER STATING THE INCIDENT WAS OBSERVED DURING THE PREPARATION FOR THE PUI (HOSPITAL PHARMACY) BEFORE DISPENSING TO THE CARE SERVICE. NO ADVERSE EVENTS, NO HUMAN HARM, NO DELAY IN THERAPY, NO BLOOD LOSS, NO PHYSICAL DEFECTS OBSERVED BEFORE USE. DRUG USED WITH THIS DEVICE: CYCLOPHOSPHAMIDE. NO LEAKAGE NOTED. THE INCIDENT WAS OBSERVED AT THE END OF PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406214 ↗
• MalfunctionJul 25, 2023Disconnection; Disconnection

  THE INCIDENT INVOLVED A SPINNING SPIROS CLOSED MALE LUER PURPLE CAP ON AN UNKNOWN DATE. THE CUSTOMER STATED THAT THERE WERE SEVERAL REPORTS BETWEEN DECEMBER 2019 AND FIRST SEMESTER OF 2020 WHERE THE PRODUCT HAD A DEFECTIVE SCREW THREAD. THE PRODUCT DOES NOT LOCK, LEADING TO DISCONNECTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389465 ↗
• MalfunctionMay 3, 2023Contamination; Particulates; Contamination; Particulates

  THE EVENT INVOLVED A SPINNING SPIROS CLOSED MALE LUER, RED CAP IN WHICH THE CUSTOMER REPORTED THAT THEY TRIED USING A VIAL SPIKE AND NOTICED A SMALL FRAGMENT OF CLEAR PLASTIC ALONG WITH A HOLE THAT CAN BE SEEN WHEN DISCONNECTED FROM THE SPIROS. THE CUSTOMER SUSPECTS THAT SPIROS DEVICE MAY CAUSE THE SILICON TO BECOME LOOSE. IT WAS NOT SPECIFIED WHETHER THERE WAS PATIENT INVOLVEMENT OR NOT. NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860184 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082806. One submission often covers many models, so check the product and lot details in each record.

• Z-1723-2022 · Aug 1, 2022 · Open, Classified
  6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
• Z-1568-2021 · Mar 16, 2021 · Open, Classified
  REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the
• Z-1567-2021 · Mar 16, 2021 · Open, Classified
  REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of
• Z-1569-2021 · Mar 16, 2021 · Open, Classified
  REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration se
• Z-0702-2021 · Aug 31, 2020 · Open, Classified
  30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Sp