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AVANOS* 46857Recalls & reported problems

Avanos Medical, Inc. · ON-Q* Pain Relief System with SELECT-A-FLOW* and Bolus, 400 ml, 2-14 ml/hr + 3 ml bolus/20 min · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494468576), received between Mar 29, 2022 and Aug 8, 2022 — classified as 4 malfunctions.

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

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-Infusion2
  • Improper Flow or Infusion1
  • Infusion or Flow Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

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

  • MalfunctionAug 8, 2022Improper Flow or Infusion; Improper Flow or Infusion

    FILL VOLUME: 550 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. THE FELLOW REPORTED ON POST OPERATION DAY, THE BALL WAS ONLY 1/3 FULL AND THEY NOTICED THE BOLUS BUTTON WAS STUCK IN THE 1/2 DOWN POSITION, CAUSING A POSSIBLE FAST FLOW. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 13JUL2022 REPORTED, THE PUMP WAS PULLED POST OP DAY ONE AND REPLACED WITH A NEW PUMP; THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15182825 ↗
  • MalfunctionApr 20, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    FILL VOLUME: 550 ML, FLOW RATE: 6 ML PER HOUR, PROCEDURE: UNKNOWN , 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 TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00039 FOR THE SECOND REPORT . IT WAS REPORTED THAT THE PUMP MAY HAVE FAILED AND COMPLETELY EMPTIED IN LESS THAN 24 HOURS. THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14161796 ↗
  • MalfunctionApr 20, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    FILL VOLUME: 550 ML, FLOW RATE: 6 ML PER HOUR, PROCEDURE: UNKNOWN, 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 TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00038 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE PUMP MAY HAVE FAILED AND COMPLETELY EMPTIED IN LESS THAN 24 HOURS. THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14161794 ↗
  • MalfunctionMar 29, 2022Infusion or Flow Problem; Infusion or Flow Problem

    FILL VOLUME: 550 ML, FLOW RATE: 6ML/HR. PROCEDURE: TOTAL KNEE AMPUTATION ON (B)(6) 2022. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP "FLOWED TOO FAST AND EMPTIED IN LESS THAN 24 HOURS." THE DEVICE WAS REPLACED FOR A NEW DEVICE. THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13942819 ↗

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.