Lifecare PCA 1427928Recalls & reported problems

ICU Medical, Inc. · Y-Type Minibore PCA Set, Integral PAV, Injector Assembly, Secure Lock, 86 Inch · Class 2

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 10887787005506), received between Mar 31, 2025 and Mar 31, 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Fluid/Blood Leak1

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.

MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED AND INVOLVED A Y-TYPE MINIBORE PCA SET, INTEGRAL PAV, INJECTOR ASSEMBLY, 0.2 MICRON FILTER, SECURE LOCK, 86 INCH WHERE THE CUSTOMER REPORTED THAT THE PCA LINE HOOKED UP TO THE PATIENT WAS LEAKING HYDROMORPHONE LEAKING. THE CUSTOMER INSPECTED THE TUBING AND FOUND IT TO HAVE A SPLIT IN IT NEAR THE VIAL AND PCA MACHINE. THE PCA LINE LINE WAS CHANGED OUT BUT HYDROMORPHONE VIAL REUSED. IMMEDIATE ACTION WAS DONE WHEN THEY REPLACED THE TUBING. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735011 ↗

Device details

UDI-DI	`10887787005506`
Brand	Lifecare PCA
Model	1427928
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.