AVANOS 13569Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494135690), received between Jun 11, 2021 and May 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K052117); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED, PUMP INFUSED MUCH FASTER THAN THE INTENDED 46 HOURS, AS EARLY AS 1 DAY. THE EVENT OCCURRED TWO YEAR AGO. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19425073 ↗
• MalfunctionJul 15, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PATIENT WAS RECEIVING 12 HOUR INFUSIONS OF FORTUM CEFTAZIDIME 3GR /142ML NACL TWICE A DAY FOR 11 DAYS. DURING THIS REPORTED EVENT, THE PATIENT RECEIVED THE INFUSED DOSE IN 1 HOUR INSTEAD OF 12 HOURS. THERE WERE NO SIDE EFFECTS OR INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED 7 JUL 2021: FILL VOLUME: 150ML. FLOW RATE: 10ML/HR. PROCEDURE: INFUSION WITH HOMEPUMP 12 HOURS TWO TIMES A DAY ¿ CEFTAZIDIME 3G WITH 142ML NACL. CATHETER PLACEMENT: ARM. INFUSION START TIME: 8AM. INFUSION STOP TIME: 9AM (SHOULD HAVE LASTED UNTIL 8PM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176324 ↗
• MalfunctionJun 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 270 ML, FLOW RATE: 2ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP INFUSED OVER 90- HOURS INSTEAD OF THE 120-HOURS INTENDED. THE PATIENT IS STABLE. THERE WAS NO REPORTED INJURY. FOLLOW-UP NOTED THE PATIENT HAS BEEN TAKING WALKS AND HOT BATHS/SHOWERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984540 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052117. One submission often covers many models, so check the product and lot details in each record.

• Z-2111-2009 · Feb 11, 2008 · Terminated
  I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medicatio
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump