Skip to content

AVANOS 34892Recalls & reported problems

Avanos Medical, Inc. · HOMEPUMP C-SERIES* Elastomeric Pump, 60 ml, 2 ml/hr · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494348922), received between Jun 9, 2022 and Jun 9, 2022 — classified as 1 injury.

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

Most reported problems

Device problems

  • Excess Flow or Over-Infusion1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Hallucination1
  • High Blood Pressure/ Hypertension1
  • Tachycardia1

Recent adverse event reports

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

  • InjuryJun 9, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    FILL VOLUME: 30 ML. FLOW RATE: 2.5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: SUBCUTANEOUS PERIUMBILICAL REGION. IT WAS REPORTED, THE KETAMINE INFUSED IN 2-HOURS INSTEAD OF 12-HOURS. THE INFUSION WAS STARTED AT 8PM AND STOPPED AT 10PM. THE PATIENT DID EXPERIENCE SYMPTOMS OF HALLUCINATION, TACHYCARDIA (110/BEATS PER MINUTE), HIGH BLOOD PRESSURE AND STRONG SEDATION. THERE WAS NO REPORTED INJURY, THE PATIENT IS "OK." THE SIDE EFFECTS DISAPPEARED DURING THE FOLLOWING MORNING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hallucination; High Blood Pressure/ Hypertension; Tachycardia

    MAUDE report 14651400 ↗

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-0585-06 · Jan 17, 2006 · Terminated
    Easypump L T 60-24 infusion pump
  • Z-0584-06 · Jan 17, 2006 · Terminated
    Easypump ST 100-1 infusion pump

Other Pump, infusion, elastomeric devices

All Pump, infusion, elastomeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.