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AVANOS 13570Recalls & reported problems

Avanos Medical, Inc. · HOMEPUMP C-SERIES*, 300 ml, 6 ml/hr · 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 00193494135706), received between Dec 8, 2020 and Dec 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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

  • Infusion or Flow Problem1

Patient problems

  • Nausea1
  • Swelling1
  • Tingling1

Recent adverse event reports

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

  • MalfunctionDec 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

    FILL VOLUME: 298 ML, FLOW RATE: 6 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2020-00180 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE PUMP INFUSED TOO QUICKLY. PATIENT EXPERIENCED NAUSEA, SWELLING OF TONGUE, AND TINGLING OF EXTREMITIES DURING INFUSION. INFUSION WAS COMPLETED WHEN PHARMACY WAS MADE AWARE. MEDROL DOSE PACK PRESCRIBED FOR TREATMENT. PATIENT CURRENTLY IN "STABLE" CONDITION AND AS RECEIVED ADDITIONAL INFUSIONS. ADDITIONAL INFORMATION RECEIVED 23-NOV-2020 INDICATED THE PHARMACY VERIFIED WITH THE PATIENT THAT SHE IS CARING FOR THE PUMP APPROPRIATELY.

    Patient problems: Nausea; Swelling; Tingling

    MAUDE report 10970726 ↗

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

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.