ICU Medical CH3034Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00840619024116), received between Nov 3, 2017 and Nov 18, 2025 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (39 reports).

9 other recalls cover devices cleared under the same FDA submission (K173477); 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH CONNECTING THE ADAPTER FULLY TO THE INFUSION SET AND THAT THEY HAD CHEMOTHERAPY LEAKING. THEY WERE ALSO AWARE OF THE NEED TO PUSH THE INFUSION SET FULLY TO THE LEDGE OF THE SPIKE AND THIS WAS SOMETIMES VERY DIFFICULT TO ACCOMPLISH. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578372 ↗
• MalfunctionOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE MIDDLE CONNECTION JOINT OF A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP REPORTEDLY CAME LOOSE AND CHEMOTHERAPY DRUG SPILLED. THIS OCCURRED WITHOUT BENDING OR PULLING DURING A PATIENT'S INFUSION OF 5FU. THERE WAS NO BLEED BACK REPORTED. THERE WAS NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357846 ↗
• MalfunctionSep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE THE REPORTER STATED ¿A LEAKAGE WAS NOTED FROM AN IV METHOTREXATE (MTX) CHEMO AT APPROXIMATELY 7PM IN WARD 8B/ PATIENT IN BED 12. THE LEAK WAS FIRST NOTICED BY THE PATIENT¿S CAREGIVER AND SUBSEQUENTLY ESCALATED TO THE WARD NURSE. IV MTX INFUSION HAD BEEN RUNNING SINCE 2PM WITH NIL LEAKAGE SEEN UNTIL 7PM. UPON INSPECTION, STAFF IDENTIFIED THE SOURCE OF THE LEAK TO BE FROM THE BAG SPIKE ADAPTOR WITH SPIROS W/RED CAP. THE LEAK WAS MINIMAL (APPROXIMATELY 1 DROP) AND WAS CONTAINED WITHOUT FURTHER ISSUES. THE TEAM REPLACED THE SET AND CONTINUED THE IV MTX INFUSION WITHOUT FURTHER INCIDENT. NO ADDITIONAL LEAKAGE WAS OBSERVED AFTER THE SET WAS CHANGED¿. THERE WAS NO SERIOUS INJURY/DEATH. NO BLOOD LOSS. NO DELAY IN CRITICAL THERAPY AND NO ADVERSE OPERATOR CONSEQUENCES. NO MED/SURG INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033691 ↗
• MalfunctionSep 4, 2025No Flow; No Flow

  THE EVENT INVOLVED A TO 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE THE CUSTOMER REPORTED THAT DRUG COULD NOT DRIP (MEDICATION UNSPECIFIED CHEMOTHERAPY) DURING PATIENT INFUSION. THERE WAS NO LEAK REPORTED. THE DEVICE WAS REPLACED AND THERAPY RESUMED WITH NO FURTHER ISSUES ENCOUNTERED. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO DELAY IN CRITICAL THERAPY AND HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968459 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED, "THE DRUG LEAKAGE FROM SPIROS". THE EVENT OCCURRED DURING INFUSION. CONCOMITANT DRUG WAS NOT USED. A CONCOMITANT DEVICE WAS NOT USED. THE DEVICE WAS USED FOR AN UNKNOWN CHEMO. THE DEVICE WAS NOT A BIOHAZARD. THERE WAS NO BLEEDBACK. THERE WAS NO DAMAGE NOTED ON THE SET, AND THERAPY RESUMED AFTER REPLACING A NEW ONE. THE MATING DEVICE WAS CH-14. THERE WAS NO DRUG EXPOSURE. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892775 ↗
• MalfunctionAug 22, 2025No Flow; No Flow

  EVENT OCCURRED ON AN UNSPECIFIED DATE REGARDING A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE THE REPORTER "STATED THAT WHEN THE NURSE ATTACHED THE BD/ALARIS SETS TO CH3034 AND THE CHEMO OR FLUSH SOLUTION, NOTHING WILL FLOW." THEY ALSO REPORTED THAT THERE WERE MULTIPLE EVENTS THROUGHOUT JULY AND THIS WEEK. THEY STATED THAT "THE CHEMO DID COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THERE WAS DELAY IN PATIENT CARE, INCREASE IN CENTRAL LINE ACCESS." THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873889 ↗
• MalfunctionJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WAS FOUND TO HAVE GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT DURING CHEMO ADMINISTRATION, THE REGISTERED NURSE (RN) NOTICED CHEMO ON THE OUTSIDE OF THE TUBING ON TOP OF THE DRIP CHAMBER. NOT SURE OF THE SOURCE OF THE LEAK ¿ CHEMO WAS POOLING ON THE OUTSIDE OF THE TUBING. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO INTUBATION WAS NECESSARY. NO SECOND DEVICE REQUIRED. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613846 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THAT AFTER THE ONE-HOUR DRUG INFUSION, LEAKS WERE OBSERVED. OXALIPLATIN WAS INVOLVED IN THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE WAS NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066783 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP THAT REPORTEDLY LEAKED AN UNSPECIFIED CHEMOTHERAPY DRUG FROM THE TUBING. THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THERE WAS NO BLEEDBACK AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901339 ↗
• MalfunctionApr 17, 2025No Flow; No Flow

  A COMPLAINT WAS RECEIVED REGARDING A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP THAT EXPERIENCED NO FLOW. IT WAS STATED IN THE REPORT THAT THE CH14 (REFERENCE #: (B)(4)) CONNECTED TO CH3034, FLUID COULDN'T DRIP. THE EVENT OCCURRED ON (B)(6) 2025 DURING INFUSION. THERE WAS CONCOMITANT DRUG, AND CONCOMITANT DEVICE INVOLVED. AN UNKNOWN CHEMO DRUG WAS INVOLVED IN THE EVENT. HERE WAS NO DELAY IN CRITICAL THERAPY AND NO BLEEDBACK WAS NOTED. THERE WAS A PATIENT INVOLVEMENT REPORTED, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859315 ↗
• MalfunctionMar 21, 2025Material Separation; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP EXPERIENCED SEPARATION. THE REPORTER STATED "AFTER CHEMO INFUSING, THE TUBE DISCONNECTED". THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661082 ↗
• MalfunctionFeb 11, 2025Particulates; Particulates

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS W/RED CAP, VENTED CAP WHERE THE CUSTOMER REPORTED AFTER INFUSING THE 5FU CHEMOTHERAPY, THEY FOUND A BLUE SCRAP IN THE DRIP CHAMBER. THERE WAS NO BLEEDBACK, NO BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/ RESTERILIZED. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO DELAY IN THERAPY AND HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356669 ↗
• MalfunctionFeb 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP EXPERIENCED LEAKAGE. THE REPORTER STATED "THE TUBE DISCONNECTED FROM PUMP SET AND LED TO LEAK". THE EVENT OCCURRED DURING INFUSION OF NIVOLUMAB. CONCOMITANT DRUG WAS USED. DEVICE WAS USED FOR CHEMO. DEVICE WAS NOT BIOHAZARD. SAMPLE PICTURE OF A PUMP CONNECTED TO A SET, THE CONNECTION BETWEEN THE BAG SPIKE ADAPTOR TO THE TO THE IV SPIKE WAS HIGHLIGHTED ARE AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS NO DELAY IN CRITICAL THERAPY. THE LEAKAGE FROM THE JUNCTION BETWEEN THE TUBE AND THE PUMP SET. THERE WAS NO SPECIFIC DAMAGE NOTED ON THE SET. THERE WAS UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL. THE DRUG DID NOT COME IN CONTACT WITH THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL. THE INTERVENTIONS FOR THE SPILLAGE WAS UNKNOWN BUT THE CHEMO SPILL CLEANED UP PER FACILITY PROTOCOL WITH SPILL KIT USED. THE LOT NUMBER IS UNKNOWN. THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309212 ↗
• MalfunctionJan 24, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED DURING DRUG INFUSION, THE TUBE BROKE. THE EVENT OCCURRED DURING INFUSION. DEVICE WAS NOT REPROCESSED/RESTERILIZED. THE PACKAGE SEALED FULLY. THERE WAS NO PROBLEM AFTER REPLACING THE SAMPLE. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF HARM OR DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232191 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THE DEVICE LEAKS FROM SPIROS. THE EVENT OCCURRED DURING INFUSION OF METHOTREXATE. THE CHEMO DIDN¿T COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. IT WAS DISCOVERED IN TIME, SO THE PATIENT/HEALTH CARE PROVIDER WERE FINE. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE SPILL KIT WAS USED. THE DEVICE WAS NOT REPROCESSED/RE STERILIZED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925830 ↗
• MalfunctionNov 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THE CH3034, AND PUMP SET ARE LOOSE THAT LEAD TO LEAKAGE. THE EVENT OCCURRED DURING INFUSION. THERE WAS CHEMO BUT DID NOT COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE CHEMO SPILL WAS CLEANED PER FACILITY PROTOCOL. THE DEVICE WAS REPLACED WITHOUT FURTHER PROBLEM. NO ISSUE WAS REPORTED ON THE PUMP SET. THE DEVICE WAS NOT REPROCESSED / RE STERILIZED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT/PATIENT HARM, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813881 ↗
• MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED, ¿5FU LEAKS FROM THE SPIROS AT 46HR.¿ THE EVENT OCCURRED DURING INFUSION. THERE WAS A CONCOMITANT DRUG WITH A CONCOMITANT DEVICE INVOLVED. THERE WAS NO BLEED BACK, WITH CHEMO, NO BIOHAZARD, AND AN UNKNOWN USER FACILITY MEDWATCH. THE DEVICE WAS NOT REPROCESSED/RESTERILIZED. THE SAMPLE IS AVAILABLE FOR RETURN. THE QUANTITY AFFECTED IS 1. A SAMPLE PHOTO IS NOT AVAILABLE. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/ PATIENT HARM, AND NO DELAY IN CRITICAL THERAPY. THE HEALTHCARE PROVIDER INFORMED THAT THE LIQUID LEAKED FROM SPIROS BUT THERE WAS NO UNPROTECTED CHEMO EXPOSURE TO THE PATIENT AND HEALTHCARE PROVIDER SINCE THE CHEMO LEAKED TO THE FLOOR. THERE WAS NO HEALTHCARE PROVIDER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556856 ↗
• MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP. UNSPECIFIED CHEMOTHERAPY REPORTEDLY LEAKED FROM THE SPIROS ON THE DEVICE DURING AN INFUSION. THERE WAS NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS UNPROTECTED CHEMO EXPOSURE.THERE WAS NO BLEEDBACK INVOLVED IN THE EVENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: Chemical Exposure

  MAUDE report 20433943 ↗
• MalfunctionMay 31, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THERE WAS AIR IN LINE DURING INFUSION OF PACLITAXEL. THERE WAS NO BLEEDBACK REPORTED. DEVICE WAS NOT REPROCESSED / RE STERILIZED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT OR PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19435548 ↗
• MalfunctionMay 24, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THERE WAS AIR IN LINE DURING INFUSION. IT WAS ALSO MENTIONED THAT THERE WAS NO CONCOMITANT DEVICE, NO BLEED-BACK, AND WITH UNKNOWN NAME OF CHEMO DRUG. THE DEVICE WAS NOT REPROCESSED OR RE STERILIZED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392124 ↗
• MalfunctionMay 24, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP IT WAS REPORTED THERE WAS AIR IN LINE DURING INFUSION. THE EVENTS OCCURRED DURING INFUSION OF AN UNKNOWN CHEMO DRUG. CONCOMITANT DRUG WAS NOT USED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THERE WAS NO PHYSICAL DAMAGED NOTED ON THE DEVICE. THERE WERE LARGE BUBBLES SEEN. IT WAS DISTAL AIR IN LINE. THERE WAS NO PROBLEM WITH THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390392 ↗
• MalfunctionMay 8, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A WHERE THE CUSTOMER STATED THAT THERE WAS AIR IN LINE DURING INFUSION. THERE WAS CONCOMITANT DRUG WITH NO CONCOMITANT DEVICE INVOLVED. THE QUANTITY AFFECTED IS 3. A SAMPLE VIDEO WAS PROVIDED SHOWING AIR IN LINE. ADDITIONALLY, THE CUSTOMER STATES THAT THERE WAS ¿AIR IN LINE¿ ALARM. THERE WERE LARGE BUBBLES SEEN. IT WAS DISTAL AIR IN LINE. THERE WAS NOT ANY PROBLEM WITH THE PUMP. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/ PATIENT HARM, AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273682 ↗
• MalfunctionJan 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED THAT DURING AN INFUSION CHEMOTHERAPY LEAKED FROM THE SPIROS. CONCOMITANT DRUG WAS NOT USED.THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND NO DELAY IN CRITICAL THERAPY. THERE WAS NO PHYSICAL DAMAGED NOTED ON THE DEVICE.THERE WAS NO UNPROTECTED CHEMO EXPOSURE IN THIS EVENT. THERE WAS NO PATIENT AND HEALTHCARE PROVIDER HARM. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL BY A SPILL KIT. THE SET WAS REPLACED AND THERAPY RESUMED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515217 ↗
• MalfunctionJan 12, 2024Material Separation; Material Separation

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE THE CUSTOMER REPORTED THAT THE SET WAS SEPARATED BETWEEN THE CH14 AND CH3034 AFTER INFUSION. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/ PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.THE SOLUTION WAS NORMAL SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506087 ↗
• MalfunctionJan 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP WHERE IT WAS REPORTED CHEMOTHERAPY LEAKED FROM THE SPIROS. THE EVENT OCCURRED AFTER INFUSION. THERE WAS NO UNPROTECTED CHEMO EXPOSURE IN THIS EVENT. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL BY A SPILL KIT. THERE WAS NO CONCOMITANT DRUG AND NO CONCOMITANT DEVICE INVOLVED. THERE WAS NO BLEED BACK NOTED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT/PATIENT HARM AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498429 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173477. One submission often covers many models, so check the product and lot details in each record.

• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1578-2021 · Mar 16, 2021 · Open, Classified
  REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration o
• Z-1580-2021 · Mar 16, 2021 · Open, Classified
  REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administrat
• Z-1577-2021 · Mar 16, 2021 · Open, Classified
  REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1579-2021 · Mar 16, 2021 · Open, Classified
  REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a
• Z-1576-2021 · Mar 16, 2021 · Open, Classified
  REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-0704-2021 · Aug 31, 2020 · Open, Classified
  3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinn
• Z-0248-2021 · Jul 6, 2020 · Terminated
  6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149.