ICU Medical 42588-05Recalls & reported problems
Icu Medical, Inc. · Transpac™ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO™ FLUSH (INFUSION PUMP) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619039585), received between Aug 23, 2019 and Aug 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE CLINICIAN RETURNED TO THE ROOM, BLOOD HAD BACKED UP THE LINE TO THE TRANSDUCER. THE REPORTER STATED, THE CLINICIAN FLUSHED THE CATHETER WHICH WAS PATENT. THEN THE CLINICIAN FLUSHED THE LINE AND NOTICED LEAKING WHERE THE LINE ATTACHES TO THE SYRINGE PUMP WHICH IS THE SHORT LINE ATTACHED TO THE PIGTAIL FLUSH DEVICE. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8925490 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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