Transpac™ 460990410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709049703), received between Jun 11, 2019 and Jun 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE EVENT INVOLVED A PEDIATRIC KIT WITH 30ML FLUSH DEVICE THAT WAS ORIGINALLY REPORTED THROUGH A VOLUNTARY MEDSUN MEDWATCH REPORT #MW5085775. IT WAS REPORTED THAT AIR WAS NOTED IN THE ARTERIAL LINE SET UP. THE LINE WAS PREPPED APPROPRIATELY WITH THE ORDERED FLUIDS, BUT ONCE CONNECTED TO THE BABY A SIGNIFICANT AMOUNT OF AIR BUBBLES WERE NOTED THROUGHOUT THE TUBING. THE LINE WAS FLUSHED, BUT IT CONTINUED TO HAVE A TON OF AIR BUBBLES THROUGHOUT. A NEW TUBING SET WAS PRIMED AND APPLIED. THERE WAS NO REPORT OF AN ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8688609 ↗

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