AVANOS 34888Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494348885), received between Mar 8, 2021 and Dec 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PUMP INFUSED IN 3 HOURS INSTEAD OF THE INTENDED 5 HOURS. THERE WAS NO VISIBLE CRYSTALLIZATION, NO BEADING ON CONNECTION AND DISCONNECTION, NO PATIENT HYPERTHERMIA, AND NO HEAT SOURCE NEARBY. FILL VOLUME: 500 ML. FLOW RATE: 100 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS NO MEDICAL INTERVENTIONS OR INJURY. THERE WERE NO NEGATIVE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062948 ↗
• MalfunctionDec 22, 2022Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PUMP INFUSED IN 3 HOURS INSTEAD OF THE INTENDED 5 HOURS. THERE WAS NO VISIBLE CRYSTALLIZATION, NO BEADING ON CONNECTION AND DISCONNECTION, NO PATIENT HYPERTHERMIA, AND NO HEAT SOURCE NEARBY. FILL VOLUME: 500 ML, FLOW RATE: 100 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, AND INFUSION STOP TIME: UNKNOWN. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS NO MEDICAL INTERVENTIONS OR INJURY. THERE WERE NO NEGATIVE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039937 ↗
• MalfunctionMar 8, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  PER ADDITIONAL INFORMATION RECEIVED 11 MAR 2021, THE HOMEPUMP DID NOT BEAD ON PLUGGING OR UNPLUGGING, NO VISIBLE CRYSTALLIZATION, NO PATIENT HYPERTHERMIA AND NO NEARBY HEAT SOURCE NO SIDE EFFECT REPORTED. THE EVENT OCCURRED AT THE PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438946 ↗
• MalfunctionMar 8, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  PER ADDITIONAL INFORMATION RECEIVED 11 MAR 2021, THE HOMEPUMP DID NOT BEAD ON PLUGGING OR UNPLUGGING, NO VISIBLE CRYSTALLIZATION, NO PATIENT HYPERTHERMIA AND NO NEARBY HEAT SOURCE NO SIDE EFFECT REPORTED. THE EVENT OCCURRED AT THE PATIENT'S HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438914 ↗

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