ICU Medical CH-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00840619023676), received between Dec 12, 2018 and Sep 2, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571224 ↗
• MalfunctionAug 18, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300423 ↗
• MalfunctionFeb 5, 2026Crack; Fluid/Blood Leak

  A CHEMOSAFELOCK BAG SPIKE REPORTEDLY LEAKED AT THE BAG SPIKE WHEN THE USER ATTEMPTED TO ADMINISTER DRUG SOLUTION AFTER CONNECTING THE DEVICE TO A CHEMOSAFELOCK INFUSION SET AND INFUSION BAG OF 5% GLUCOSE INJECTION (OTSUKA). WHEN THE CLINICIAN CHECKED THE LIQUID FLOW UNDER GRAVITY AFTER OPENING THE CLAMP, LEAKAGE WAS CONFIRMED AT THE CONNECTION BETWEEN THE SPIKE AND THE BODY. UPON CLOSELY CHECKING THIS CONNECTION, A CRACK WAS FOUND AT THE ROOT OF THE SPIKE. NO ANOMALIES SUCH AS BENDING OR DAMAGE WERE FOUND ON THE SPIKE TIP THAT COULD HAVE CONTRIBUTED TO PENETRATION FORCE. NO STRESS MARKS OR DENTS WERE OBSERVED ON THE BODY EITHER. THE EVENT WAS NOT DETECTED PRIOR TO PATIENT USE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO DELAY IN CRITICAL THERAPY, NO ADVERSE OPERATOR CONSEQUENCES, NO UNPROTECTED CHEMO EXPOSURE AND NO MEDICAL/SURGICAL INTERVENTION WERE REQUIRED. THE DEVICE WAS CHANGED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO REPORTED HARM TO THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268277 ↗
• MalfunctionFeb 4, 2026No Flow

  AN UPDATE HAS BEEN MADE TO THE EVENT DESCRIPTION. ¿ THE PRODUCT USED FOR MAXIMUM OF 2 HOURS BEFORE THE ISSUE OCCURRED. ¿ THERE WAS PATIENT INVOLVEMENT. ¿ THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259665 ↗
• MalfunctionNov 9, 2025Particulates; Particulates

  AN EMAIL WAS RECEIVED REGARDING A CHEMOCLAVE® BAG SPIKE ALLEGING THAT PARTICULATES ARE FLOATING IN THE PATH OF THE PATIENT. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507151 ↗
• MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOSAFELOCK BAG SPIKE THAT EXPERIENCED LEAKAGE. IT WAS STATED IN THE REPORT, ¿LEAKAGE¿. TRANSLATED FROM JAPANESE: "A PATIENT RECEIVING CYRAMZA VIA CHEMOSAFELOCK EXPERIENCED LEAKAGE FROM THE CONNECTION BETWEEN THE BAG SPIKE AND THE INFUSION SET. AFTER CONNECTING THE BAG SPIKE AND THE ROUTE, THE NURSE WAS OBSERVING THE INFUSION FOR ABOUT FIVE MINUTES WHEN LEAKAGE OCCURRED FROM THE BAG SPIKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779819 ↗
• MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CHEMOCLAVE® BAG SPIKE 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. THE DEVICE WAS NOT RE-STERILIZED OR REPROCESSED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584213 ↗
• MalfunctionJan 15, 2025Particulates; Particulates

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE THE CUSTOMER REPORTED THAT THE THERE FOREIGN MATERIAL ON THE SPIKE. THE SETS WERE NOT CONTAMINATED WITH BLOOD OR BODY FLUID. THERE WAS NO REPORTED IMPACT OF EVENT ON PATIENT AND MEDICAL INSTITUTION WORKER. THERE WERE 2 INVOLVED DEFECTIVE SETS. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162752 ↗
• MalfunctionJan 14, 2025Crack; Crack

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE THAT REPORTEDLY LEAKED AFTER USE. THERE WAS NO REPORTED IMPACT OR HARM ON ANY PATIENT OR MEDICAL INSTITUTION WORKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21153762 ↗
• MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE IT WAS REPORTED THERE WAS LEAKAGE. THE EVENT OCCURRED AFTER USE. THERE WAS NO REPORTED IMPACT OF EVENT ON PATIENT AND MEDICAL INSTITUTION WORKER, UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151519 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE IT WAS REPORTED THERE WAS LEAKAGE. THE EVENT OCCURRED AFTER USE. THERE WAS NO REPORTED IMPACT OF EVENT ON PATIENT AND MEDICAL INSTITUTION WORKER, UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145620 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SUSPECTED LOT NUMBER IS 13988483. THE CUSTOMER RETURNED THE DEVICE TO TERUMO FACTORY AND IT WAS REPORTED "LEAKAGE AT THE CONNECTION BETWEEN THE CONCERNED PRODUCT AND A CHEMOSAFELOCK INFUSION SET. ONE (1) ACTUAL SAMPLE WAS RECEIVED CONNECTED TO A PALONOSETRON I.V.INFUSION BAG. IN ADDITION, CHEMOSAFELOCK INFUSION SET (KL-AF3H01N) WAS ALSO RECEIVED. NO DAMAGES OR DEFORMATION WERE CONFIRMED, INCLUDING THE MAIN SEAL. WHEN WE CONNECTED THE SAMPLE TO OUR IN-HOUSE SALINE BAG AND CHEMOSAFELOCK INFUSION SET TO CHECK LIQUID FLOW, LEAKAGE WAS CONFIRMED AT THE BACK OF CLIPS OF CHEMOSAFELOCK CONNECTOR. WHEN WE CHECKED LIQUID FLOW AFTER REPLACED THE SAMPLE TO OUR IN-HOUSE KL-BS001U3, NO LEAKAGE WAS OBSERVED. CT INSPECTION WAS PERFORMED ON THE CONNECTION BETWEEN THE SAMPLE AND A KL-MSU3, WHEREIN THE DEFORMED CONDUIT AND A GAP BETWEEN THE CONDUIT AND SEAL PART WERE CONFIRMED. THE EVENT OCCURRED DURING INFUSION OF : PALONOSETRON I.V.INFUSION BAG ¿TAIHO¿ 50ML. CHEMOSAFELOCK INFUSION SET(KLAF3H01N) WAS THE IDENTIFIED MATING DEVICE. TYPE OF PROCEDURE IS DRUG INFUSION. THE EVENT WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO SERIOUS INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127231 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED ON 23-JAN-2025 FROM (B)(6) ON BEHALF OF MR. (B)(6) FROM TERUMO KOFU FACTORY - QUALITY ASSURANCE SECTION STATING THAT BASED ON THE SAMPLE EVALUATION, THEY WERE NOT ABLE TO IDENTIFY ANY IRREGULAR PHYSICAL PROPERTIES THAT SUGGEST THE POSSIBILITY OF MANUFACTURE-ORIGIN. HENCE, THEY DETERMINED NOT TO REQUEST ANY INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21127203 ↗
• MalfunctionJan 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE A LEAKAGE WAS REPORTED. THE USE OF THE ACTUAL SAMPLE WAS AFTER USE. THE SET WAS NOT CONTAMINATED WITH BLOOD OR BODY FLUID. THERE WAS NO REPORTED IMPACT OF THE EVENT ON THE PATIENT OR THE MEDICAL INSTITUTION WORKER. IN ADDITION, THE CUSTOMER STATED THAT THE LEAKAGE OCCURRED IN BETWEEN A BAG SPIKE AND AN INFUSION LINE. ONE ACTUAL SAMPLE WAS RECEIVED CONNECTED TO A SALINE BOTTLE(OTSUKA/100ML) AND AN INFUSION SET. - WE REMOVED THE ACTUAL SAMPLE FROM THE SALINE BOTTLE AND CONNECTED TO OUR IN-HOUSE SALINE BOTTLE TO PERFORM LIQUID FLOW CHECK UNDER GRAVITY. THE RESULT RECORDED LEAKAGE AT THE BACK SIDE OF CLIPS OF CHEMOSAFE CONNECTOR. - AFTER CHANGED THE RETURNED SAMPLE TO OUR INHOUSE KL-BS001U3 TO CHECK THE LIQUID FLOW UNDER GRAVITY, NO LEAKAGE WAS OBSERVED. - CT INSPECTION WAS PERFORMED. THE RESULT RECORDED DEFORMED CONDUIT AND A GAP BETWEEN THE SEAL PART AND CONDUIT.- NO DAMAGE WAS OBSERVED ON THE MAIN SEAL PART. WHEN WE APPLIED PRESSURE SOLELY ON THE ACTUAL SAMPLE, NO LEAKAGE WAS OBSERVED. THE EVENT WAS DETECTED PRIOR TO PATIENT USE. THE EVENT WAS NOTED DURING INFUSION. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO ADVERSE OPERAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102030 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED CHEMOSAFELOCK BAG SPIKE WHERE THE CUSTOMER REPORTED, TO TERUMO, THAT A LEAK OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORTED IMPACT OF THE EVENT ON THE PATIENT AND MEDICAL INSTITUTION WORKER. THE CUSTOMER RETURNED ONE SAMPLE TO TERUMO FOR EVALUATION. WHEN TERUMO PERFORMED LIQUID FLOW CHECK UNDER GRAVITY AFTER CONNECTED THE SAMPLE TO OUR IN-HOUSE SALINE BAG AND THE RETURNED INFUSION SET(KL-AF3H01Y), LEAKAGE WAS CONFIRMED AT THE BACK OF CLIPS OF CHEMOSAFE LOCK CONNECTOR. AFTER, CHANGED THE SAMPLE TO THEIR IN-HOUSE KL-BS001U3, LIQUID FLOW WAS CHECKED UNDER GRAVITY AND NO LEAKAGE WAS OBSERVED. CT INSPECTION WAS PERFORMED. THE RESULT RECORDED DEFORMED CONDUIT AND A GAP BETWEEN THE SEAL PART AND CONDUIT. THE REPORTED ISSUE WAS CONSIDERED TO BE A PRODUCTION-ORIGIN ISSUE, BASED ON TERUMO'S SAMPLE EVALUATION RESULTS. THERE WAS NO SERIOUS INJURY OR DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO DELAY IN CRITICAL THERAPY, NO ADVERSE OPERATOR CONSEQUENCES, AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE DEVICE WAS CHANGED OUT OR REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034934 ↗
• MalfunctionDec 13, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE IT WAS REPORTED THERE WAS LEAKAGE. LEAKAGE OCCURRED IN BETWEEN A BAG SPIKE AND CONNECTOR DURING INFUSION. ONE ACTUAL SAMPLE WAS RECEIVED CONNECTED TO A SALINE BOTTLE (50ML). WITH ¿AS-RECEIVED¿ CONDITION, WE APPLIED PRESSURE TO THE BOTTLE. NO LEAKAGE WAS OBSERVED. UPON CLOSELY CHECKING THE TOP SURFACE OF THE CONNECTOR OF THE ACTUAL SAMPLE, NO DAMAGE WAS CONFIRMED IN THE MAIN SEAL. CONNECTED OUR IN-HOUSE KL-MSU3 TO THE ¿AS RECEIVED¿ SAMPLE AND LIQUID FLOW WAS CHECKED UNDER GRAVITY. LEAKAGE WAS CONFIRMED AT THE BACK OF CLIPS OF KL-MSU3. CT INSPECTION WAS PERFORMED. THE RESULT SHOWS THE DISTORTION OF CONDUIT NEAR THE OPENING (CLOSE TO SPIKE SIDE). KL-AT30L1AYA WAS THE MATING DEVICE. FLUOROURACIL WAS THE MEDICATIONS INVOLVED. KL-AT30L1AYA WAS THE MATING DEVICE INVOLVED. THE EVENT WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO DELAY IN CRITICAL THERAPY, NO ADVERSE OPERATOR CONSEQUENCES AND NO MEDICAL/SURGICAL INTERVENTION WERE REQUIRED. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929394 ↗
• MalfunctionDec 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE A FOREIGN MATERIAL WAS REPORTED. USE OF ACTUAL SAMPLE WAS BEFORE USE TO THE PATIENT. THE SET WAS NOT CONTAMINATED WITH BLOOD OR BODY FLUID. THERE WAS NO REPORTED IMPACT OF EVENT ON PATIENT AND MEDICAL INSTITUTION WORKER. BASED ON THE SAMPLE EVALUATION, THEY WERE NOT ABLE TO IDENTIFY ANY IRREGULAR PHYSICAL PROPERTIES THAT SUGGEST THE POSSIBILITY OF MANUFACTURE-ORIGIN. HENCE, THEY DETERMINED NOT TO REQUEST ANY INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843074 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE A LEAK DURING INFUSION WAS REPORTED. AFTER PREPARED AND CONNECTED TO THE DISTAL END OF THE LINE, IT WAS LEFT FOR 30MINUTES. WHEN THE USER ATTEMPTED TO START INFUSION, THEY FOUND MUCH AMOUNT OF SOLUTION LEAKED AT THE CONNECTION. ONE(1) ACTUAL SAMPLE WAS RETURNED CONNECTED TO A SALINE BAG(OTSUKA). IN ADDITION, CHEMOSAFELOCK INFUSION SET(KL-AF30L1AYA), AND THREE(3) PCS. UNOPENED SAMPLES OF SAME LOT WITH THE ACTUAL SAMPLE. AFTER CONNECTED THE SAMPLE TO OUR IN-HOUSE SALINE BAG AND THE RETURNED CHEMOSAFELOCK INFUSION SET, WE CHECKED THE LIQUID FLOW UNDER GRAVITY. AS A RESULT, LEAKAGE WAS CONFIRMED AT THE CONNECTOR. FOR THREE(3) PCS. OF SAME LOT SAMPLES, NO LEAKAGE WAS CONFIRMED DURING THE LIQUID FLOW CHECK PERFORMED UNDER GRAVITY. WHEN WE APPLIED PRESSURE ON THE BAG CONNECTED TO THE ACTUAL SAMPLE, LEAKAGE WAS CONFIRMED AT THE TOP SURFACE OF THE SAMPLE. UPON CLOSELY CHECKING, DAMAGE WAS CONFIRMED AT THE MAIN SEAL. TE-281A, EXTENSION TUBE, I.V.CATHETER AND KL-AF30L1AYA ARE THE IDENTIFIED INVOLVED MATING DEVICES. PREPARATION WAS THE TYPE OF PROCEDURE. PACLITAXEL WAS THE MEDICATION INVOLVED. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842977 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE A LEAK DURING INFUSION WAS REPORTED. THE INVOLVED AND/OR MATING DEVICES IS CHEMOSAFELOCK INFUSION SET. TYPE OF PROCEDURE IS PREPARATION AND MEDICATION INVOLVED IS KEYTRUDA. AS PER REPORT, "ONE(1) ACTUAL SAMPLE WAS RETURNED CONNECTED TO A SALINE BAG (100ML/OTSUKA). WITH ¿AS-RECEIVED¿ CONDITION, WHEN WE APPLIED PRESSURE TO THE SALINE BOTTLE, NO LEAKAGE WAS OBSERVED. AFTER CONNECTED THE SAMPLE TO THE SALINE BOTTLE, AND OUR IN-HOUSE KL-MSU3, LIQUID FLOW AS CHECKED UNDER GRAVITY. AS A RESULT, THE SOLUTION WAS CONFIRMED TO BE LEAKING FROM THE BACK OF KL-MSU3¿S CLIPS. UPON CLOSELY CHECKING OF THE TOP SURFACE OF THE SAMPLE, DAMAGE WAS CONFIRMED ON THE MAIN SEAL PART. THERE WAS NO REPORTED IMPACT OF THE EVENT ON PATIENT AND MEDICAL INSTITUTION WORKER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842940 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE THE CUSTOMER REPORTED A LEAKAGE DURING INFUSION. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO DELAY IN CRITICAL THERAPY, NO ADVERSE OPERATOR CONSEQUENCES, AND NO MED/SURG INTERVENTION REQUIRED. THE DEVICE(S) WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. MATING DEVICE IS KL-AF30L1AY. TYPE OF PROCEDURE WAS PREPARATION THE MEDICATION INVOLVED WAS 5FU. ONE PHYSICAL SAMPLE WAS RECEIVED IN THE OPENED PACKAGE. UPON VISUALLY CHECKING THE SAMPLE, TEARING WAS CONFIRMED ON THE TOP SURFACE OF MAIN SEAL. WE CONNECTED THE SAMPLE TO OUR IN-HOUSE SALINE BOTTLE AND APPLIED PRESSURE TO THE BOTTLE. AS A RESULT, LEAKAGE OCCURRED AT THE DAMAGED PORTION ON THE TOP SURFACE OF THE SAMPLE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692142 ↗
• MalfunctionNov 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT INVOLVED A CHEMOSAFELOCK BAG SPIKE WHERE THE CUSTOMER REPORTED A FOREIGN MATERIAL (CORING). THERE WAS NO REPORTED IMPACT OF THE EVENT ON THE PATIENT AND MEDICAL INSTITUTION WORKER. THE PRODUCT IS NOT CONTAMINATED WITH BLOOD OR BODY FLUID. THE EVENT WAS NOTED BEFORE USE TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676106 ↗
• MalfunctionNov 7, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOSAFELOCK BAG SPIKE THAT EXPERIENCED LEAKAGE DURING PATIENT USE. THE REPORTER STATED, ¿LEAKAGE." THE EVENT OCCURRED AFTER USE. THE SAMPLE IS NOT CONTAMINATED WITH BLOOD OR BODY FLUID. THERE WAS NO REPORTED IMPACT OF EVENT ON PATIENT. THERE WAS NO REPORTED IMPACT ON MEDICAL INSTITUTION WORKER. THE AFFECTED SAMPLE IS AVAILABLE TO BE SENT FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED 08-OCT-2024 STATING "LEAKAGE WAS OBSERVED AT THE BONDING PORTION BETWEEN THE CONNECTOR AND SPIKE DURING INFUSION." ONE(1) ACTUAL SAMPLE WAS RECEIVED CONNECTED TO A SALINE BOTTLE(OTSUKA/100ML). WITH ¿AS-RECEIVED¿ CONDITION, OUR IN-HOUSE KL-MSU3 AND SYRINGE, WHICH IS FILLED WITH WATER, WERE CONNECTED TO THE SAMPLE, AND INFUSION/ASPIRATION PERFORMANCE WAS TESTED. AS A RESULT, LEAKAGE WAS CONFIRMED IN BETWEEN THE BODY AND SPIKE. ALTHOUGH NO ANOMALIES WERE VISUALLY CONFIRMED, WHEN WE SLIGHTLY ROTATED THE CONNECTION PART BETWEEN BODY AND SPIKE, THE CONNECTION WAS REMOVED. UPON CLOSELY CHECKING THE CONNECTION PART, ALMOST NO TRACE OF ADHESIVE WAS CONFIRMED, AND RESIN WAS PRESENT ON THE INNER WALL OF THE MALE TAPER TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635165 ↗
• MalfunctionOct 25, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WHERE IT WAS REPORTED THAT THE PATIENT NOTICED AND NOTIFIED NURSE THAT CYCLOPHOSPHAMIDE BAG HAD DRIPS BUT "NOT CONSTANT." NURSE DONNED PERSONAL PROTECTIVE EQUIPEMENT (PPE) GLOVES AND GOWN. NURSE TOOK BAG OFF POLE AND HAD HAND NEAR SPIKE AND SPIKE BROKE OFF AND SEVERAL DROPS GOT ON THE FLOOR. SPILL CONTAINED AND SPILL KIT OBTAINED AND DROPS WIPED WITH SPILL RAG AND DISPOSED OF IN BAG AND BAG PLACE IN CHEMO BIN. NOTIFIED PHARMACY AND NOTIFIED EVS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20538914 ↗
• MalfunctionOct 25, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WHERE IT WAS REPORTED THAT UPON RECEIVING THE FIRST BAG OF CYCLOPHOSPHAMIDE IN A 250ML BAG OF NS, 20 MINS INTO THE INFUSION, THE BAG HAD SMALL BUBBLES COMING OUT OF THE CHEMO SPIKE. THE DRUG WAS REMOVED AND PLACED IN A CHEMO BAG AND TAKEN BACK TO PHARMACY, REPORTED PHARMACY THE AMOUNT OF DRUG INFUSED. THERE WAS NO DRUG LEAKED ON THE FLOOR OR THE PATIENT. PER MD TEAM, MD WANTED THE REMAINDER OF THE DOSE NOT GIVEN TO BE MIXED AGAIN AND GIVEN TO THE PATIENT. PHARMACY WAS NOTIFIED. THE SECOND BAG OF CYCLOPHOSPHAMIDE CAME IN A 500ML BAG OF D5W, THE PATIENT RECEIVED THE DRUG WITH NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM AS THERE WAS NO CHEMO EXPOSURE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537892 ↗
• MalfunctionOct 25, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOCLAVE® BAG SPIKE WHERE IT WAS REPORTED THE INFUSION PUMP ALARMED INFUSION COMPLETE. THIS REGISTERED NURSE (RN) PRESENTED TO CHAIRSIDE TO SWITCH INFUSION SET TO FLUSH. BEFORE DISCONNECTING INFUSION SET FROM CYCLOPHOSPHAMIDE BAG, THIS RN NOTICED A CRACK IN THE BAG SPIKE WITH BAG CONTENTS LEAKING OUT. NOTIFIED SECOND RN WITH APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). APPROXIMATELY 5MLS OF BAG CONTENTS FOUND ON FLOOR AT BASE OF INFUSION PUMP. CONTENTS OF BAG DID NOT REACH PATIENT PER RN OBSERVATION AND PATIENT SELF-REPORT. CHEMO SPILL KIT OBTAINED AND TREATED PER POLICY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM AS THERE WAS NO CHEMO EXPOSURE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535182 ↗

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-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-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-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-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-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-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.