Lifecare PCA 1427828Recalls & reported problems

ICU Medical, Inc. · Y-Type Minibore PCA Extension Set - 10 Inch, Secure Lock · Class 2

Data updated Oct 16, 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 10887787005483), received between Aug 5, 2025 and Aug 5, 2025 — 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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak1
Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionAug 5, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
EVENT OCCURRED REGARDING NDEHP PCA EXT SET 10IN WVALVE WHERE THE REPORTER STATED THAT 2 PARTS OF THE IV SNAPPED DURING INFUSION AND THE PATIENT'S DRUG BEGAN TO LEAK. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN THERAPY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22723499 ↗

Device details

UDI-DI	`10887787005483`
Brand	Lifecare PCA
Model	1427828
Company	ICU Medical, Inc.
Product code	MEA · Pump, infusion, pca
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 17, 2025

Device type (GMDN): Electric infusion pump administration set, single-use

A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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