ICU Medical 42800-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709097995), received between Aug 4, 2023 and Feb 25, 2025 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K052828); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, MACRODRIP WHERE IT WAS REPORTED THAT WHILE ATTEMPTING TO GET PATIENT READY TO TRANSPORT FOR CT, ARTERIAL LINE TUBING BECAME DISCONNECTED, CAUSING BLOOD TO FLOW FREELY. BEDSIDE MONITOR ALARMED AND ISSUE WAS DISCOVERED QUICKLY, SO BLOOD LOSS WAS MINIMAL. NO CLEAR EPISODE OF ANYTHING GETTING CAUGHT ON TUBING CAUSED THE SEPARATION OF TUBING. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21462005 ↗
• DeathFeb 16, 2024Disconnection; Disconnection

  THE EVENT INVOLVED TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, MACRODRIP WHERE A DISCONNECTION OF TUBING AT BLOOD SAMPLING PORT WAS REPORTED. THE PRODUCT WAS NOT DISCOLORED DURING THE ENTIRE USE. THE EVENT OCCURRED DURING INFUSION AND THERE WAS PATIENT HARM DUE TO BLEEDING THAT OCCURRED WHEN THE DEVICE MALFUNCTIONED AND BROKE APART. THE PATIENT NEEDED TO BE TURNED AND REPOSITIONED FOR CLEAN-UP. PATIENT SUSTAINED RESPIRATORY ARREST WHILE STAFF WAS ATTEMPTING TO CLEAN THE PATIENT UP. PATIENT THEN EXPIRED ONE DAY AFTER INITIAL ARREST AND PRODUCT ISSUE, AND AFTER BEING MADE COMFORT CARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18727280 ↗
• MalfunctionJan 17, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT A TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, MACRODRIP DISCONNECTED DURING PATIENT USE ON PATIENT. THE PRODUCT APPEARS TO HAVE FAILED AT THE DISTAL CAD PORT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531911 ↗
• MalfunctionAug 4, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT A TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML FLUSH DEVICE, MACRODRIP SQUEEZE FLUSH MECHANISM APPEARS ¿TURNED¿ AND WHEN THE REGISTERED NURSE (RN) TRIED TO STRAIGHTEN IT, IT BEGAN LEAKING FROM THE FLUSH MECHANISM AREA. THE PRODUCT WA USED FOR ONE HOUR. THERE WAS PATIENT INVOLVED BUT NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461109 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06