Lifeshield 1422128Recalls & reported problems
ICU Medical, Inc. · Primary Set, Secure Lock, 100 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 10887787006442), received between Jun 28, 2023 and Jun 28, 2023 — 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.
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.
MalfunctionJun 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY AND INVOLVED A PRIMARY SET, SECURE LOCK, 100 INCH WHICH WAS REPORTED TO HAVE LEAKING AT THE PATIENT BEDSIDE DURING PATIENT INFUSION. THE CUSTOMER REPORTED THAT THE LEAK WAS NOTICED IMMEDIATELY AND OBSERVED TO BE LEAKING BETWEEN THE SPIKE AND THE CHAMBER. THE AFFECTED PRODUCT WAS INFUSING CAR T CELLULAR THERAPY ABECMA - RE-ENGINEERED CELLS. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17216928 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.