ICU Medical CH3531Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709074057), received between Apr 10, 2023 and Jun 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K070532); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/MICROCLAVE®, 0.2 MICRON LOW PROTEIN BINDING FILTER, 2 CLAMPS, SPIROS® W/RED CAP AND OCCURRED ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING (PACLITAXEL) TAXOL. THE LAST ADMISSION TOWARD THE END OF INFUSION FILTER BROKE AND MEDICATION PRECIPITATED. THIS ADMISSION AT HOUR 19 AND HOUR 21 OF THE 24-HOUR INFUSION FILTER BROKE AGAIN. IT WAS NOTED THAT THE CONCENTRATION OF MEDICATION MAY BE TOO HIGH FOR THE TUBING. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460598 ↗
• MalfunctionMay 16, 2024No Flow; No Flow

  ICU MEDICAL RECEIVED AN EMAIL ON FROM REPRESENTATIVE OF (B)(6) HOSPITAL REGARDING A 12" (30 CM) EXT SET W/MICROCLAVE®, 0.2 MICRON LOW PROTEIN BINDING FILTER, 2 CLAMPS, SPIROS® W/RED CAP RESULTED IN NO FLOW OF INFUSION. THE REPORT STATED THAT PATIENT WAS RUNNING ATG WITH FILTER, 4 HOURS INTO 6-HOUR INFUSION PUMP ALARMED PATIENT SIDE OCCLUSION, REGISTERED NURSE (RN) FLUSHED AT CLAVE, FLUSHED WITH NO ISSUES, BUT PUMP KEPT BEEPING PATIENT SIDE OCCLUDED. NOT A PUMP ISSUE, RN SPOKE WITH NURSE PRACTITIONER AND PHARMACIST ABOUT WASTE AMOUNT OF FILTER (5 MLS), NEGLIGIBLE AMOUNT BASED ON DOSE PER PHARMACIST. RN CHANGED OUT SPIROS FILTER FOR REGULAR 0.2-MICRON FILTER WITHOUT SPIROS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332141 ↗
• MalfunctionApr 10, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT MISSED OUT AN APPROXIMATELY 5ML OF EPOCH CHEMO THAT WAS IN THE FILTER (4ML) AND APPROXIMATELY 1ML THAT HAD DRIPPED FROM THE FILTER. THE CHEMOTHERAPY SPILL WAS CLEANED UP AS PER FACILITY PROTOCOL AND A SPILL KIT WAS NOT USED. THE LEAK OCCURRED ON DAY 4 OF 5 OF INFUSION. THE SET UP WAS PER ICS STANDARD WITH SPIROS AND C-CLAMPS AT ALL CONNECTIONS ON LARGE BORE TUBING, WITH THE FILTER, CONNECTED TO A TRIFUSE ATTACHED TO THE PORT TUBING. THERE WERE NO HOLES, CUTS, TEARS OR ANY DEFECT IDENTIFIED WITH THE FILTER WHEN THE LEAK WAS FOUND TO BE COMING FROM THE TWO HOLES ON THE BACK OF THE FILTER. A CRACK ON THE FILTER WAS NOT OBSERVED DURING THE EVENT. WHEN ASKED, "WAS THE LEAK NOTED AT THE TUBING/FILTER CONNECTION OR AT THE AIR VENTS?" THE CUSTOMER RESPONDED, "IF THE 'HOLES' ON THE BACK OF THE FILTER ARE THE AIR VENTS, THEN THAT IS WHERE THE LEAK WAS NOTED." THERE WAS A DELAY IN THERAPY AS THE INFUSION WAS PAUSED FOR LESS THAN 10 MINUTES TO ASSESS WHERE THE LEAK WAS COMING FROM. THE FILTER WAS REMOVED AND THE INFUSION RESUMED. MEDSUN MEDWATCH MANDATORY REPORTING UF/IMPORTER REPORT #(B)(4) WAS RECEIVED WHICH STATED, "PAT

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

  MAUDE report 16707119 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070532. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2021 · Aug 31, 2020 · Open, Classified
  42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, RE