AVANOS 13554Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494135546), received between Jan 11, 2021 and Feb 7, 2022 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 350ML . FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP DIFFUSED IN 1 HOUR 30 MINUTES INSTEAD OF 3 HOURS. THE PRODUCT ADMINISTERED AS 1G SOLUMEDROL IN 350ML OF 0.9% SALINE. NO FURTHER INFORMATION WAS PROVIDED. PER ADDITIONAL INFORMATION RECEIVED, "FOLLOWING THE MORE RAPID DIFFUSION OF CORTICOSTEROIDS, THE PATIENT HAD A SLIGHT TACHYCARDIA WHICH FADED SPONTANEOUSLY. AFEBRILE THROUGHOUT HIS CORTICOSTEROID TREATMENT."

  Patient problems: Tachycardia

  MAUDE report 13476440 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW5098016 THE FOLLOWING INFORMATION: FILL VOLUME: 350 ML, FLOW RATE: 100ML/HR, PROCEDURE: ANTIBIOTIC THERAPY, CATHPLACE: UNKNOWN, INFUSION DATE(S): MULTIPLE INFUSIONS (B)(6), ADMINISTERED STARTING (B)(6) 2020, INFUSION TIME OF EACH THERAPY: 3.5 HOURS, START AND STOP TIME: UNKNOWN, (PATIENT SELF ADMINISTERED AT HOME). PATIENT HAD BEEN ON VABOMERE 4GM IV Q8H VIA GRAVITY SINCE (DATE REDACTED)2020 FOR TREATMENT OF PERSISTENT HEPATIC ABSCESSES/BACTEREMIA WITH RESISTANT ORGANISMS STARTING (DATE REDACTED)2020 PATIENT REPORTED RIGHT SIDED FLANK PAIN ASSOCIATED WITH THE END OF HIS INFUSIONS PAIN REPORTEDLY STARTED AFTER HE STARTED USING THE ELASTOMERIC DEVICES DESCRIBES PAIN AS BURNING SENSATION THAT SEEMED TO LESSEN IN SEVERITY AD TIME PROGRESSED AFTER HIS INFUSIONS REPORTS PAIN IS WITH LIGHT TOUCH AND IS 4/10 WHEN HE'S UP AND WALKING NO OTHER SYSTEMIC SIGNS/SYMPTOMS OR RASH NOTED BILIARY DRAIN NOTED TO BE WORKING PROPERLY WITH STABLE LABS (DATE REDACTED)2020 ON (DATE REDACTED)2020. PATIENT WAS SWITCHED BACK TO GRAVITY INFUSIONS FOR REMAINDER OF HIS ANTIBIOTIC THERAPY ON (DATE REDACTED)2020, PATIENT REPORTED THAT PAIN RESOLVED A

  Patient problems: Burning Sensation; Pain

  MAUDE report 11150268 ↗

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