ICU Medical 42800-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709097629), received between Sep 6, 2022 and Sep 8, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 60", 3ML FLUSH DEVICES, MACRODRIP (POLE MOUNT). THE CUSTOMER REPORTED THAT THE DEVICE CAME BACK REPACKED AS DEFECTIVE AS IT DISCONNECTED WHILE IN USE DURING A CASE. THERE WAS NO REPORT OF HUMAN HARM AND NO OTHER INFORMATION IS AVAILABLE REGARDING THIS REPORTED ISSUE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380807 ↗
• MalfunctionSep 6, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 60", 3ML FLUSH DEVICES, MACRODRIP (POLE MOUNT) WHERE IT WAS REPORTED THAT THE PRODUCT KEPT ON DISCONNECTING WHILE IN USE. TEST DONE WITH THE PRODUCT AND THE PARTS DISCONNECTED. THE PATIENT WAS FRESH POST OPERATION FROM THE OPERATING ROOM (OR). A FEW MINUTES LATER, ALL THREE OF THE FLUSH LINES CONNECTED TO THE TRANSDUCERS BROKE APART ONE BY ONE. THERE WAS A BLOOD BACK FLOW FROM THE ARTERIAL LINE. THEY ENDED UP CHANGING THE WHOLE SYSTEM. IT WAS STATED THAT THE SET UP WAS FINE WITH NO PROBLEM. TRANSDUCER TUBES BROKE APART AND SEPARATED FROM TRANSDUCER AND STARTED LEAKING WHILE THE PATIENT WAS IN CARDIAC SURGERY INTENSIVE CARE UNIT (CSICU). THE SETUP WAS IN THE MORNING AND PATIENT LEFT OR BY NOON TO CSIC. IN CSICU, THE TUBES STARTED TO BECOME LOSE AND LEAKING FLUID AND BLOOD BACKFLOW, THEY CHANGED THE SET-UP IMMEDIATELY UPON PATIENT ARRIVAL TO THE FLOOR. THERE WAS A SMALL AMOUNT OF BLOOD LEAK. THE STATUS DURING SET-UP WAS FINE BUT AFTER TRANSPORTING PATIENT CSIC THE TRANSDUCER STARTED TO LEAK, AND TUBES SEPARATE. ADDITIONALLY, IT WAS REPORTED ON THE MEDWATCH REPORT THAT "ALL 3 OF THE PIGTAILS OF THE ICU MEDICAL TRANSPAC IV T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362252 ↗

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