AVANOS 13563Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494135638), received between Apr 10, 2023 and Nov 27, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (4 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.

• MalfunctionNov 27, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2024-00067 FOR THE SECOND EVENT. FILL VOLUME: 65 ML, FLOW RATE: 5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. "PUMP INFUSED AT SIGNIFICANTLY HIGHER RATE THAN 5 ML PER HOUR. 1300 MG LIDOCAINE 2% (65 ML) INFUSED OVER 7-8 HOURS RISKING PRECIPITOUS SIDE EFFECTS. PATIENT UNHARMED..." THE ROOM TEMPERATURE WAS (22°C / 72°F). THE PUMP WAS BELOW THE CATHETER, FOUR INCHES (DISTANCE BETWEEN THE PUMP AND CATHETER. THE TUBING WAS UNDER THE PATIENT'S CLOTHING AND/OR BLANKET. ABOUT 20-MINUTES ELAPSED BETWEEN FILLING THE PUMP AND STARTING THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799668 ↗
• MalfunctionNov 27, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2024-00066 FOR THE FIRST EVENT. FILL VOLUME: 65 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. "PUMP INFUSED AT SIGNIFICANTLY HIGHER RATE THAN 5 ML PER HOUR. 1300 MG LIDOCAINE 2% (65 ML) INFUSED OVER 7-8 HOURS RISKING PRECIPITOUS SIDE EFFECTS. PATIENT UNHARMED..." THE ROOM TEMPERATURE WAS (22°C / 72°F). THE PUMP WAS BELOW THE CATHETER, FOUR INCHES (DISTANCE BETWEEN THE PUMP AND CATHETER. THE TUBING WAS UNDER THE PATIENT'S CLOTHING AND/OR BLANKET. ABOUT 20-MINUTES ELAPSED BETWEEN FILLING THE PUMP AND STARTING THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799438 ↗
• MalfunctionApr 10, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 2026095-2023-00045 FOR THE FIRST REPORT.. FILL VOLUME: UNKNOWN. FLOW RATE: 5ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN SUBCUTANEOUS. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMPS SEEMED TO INFUSE TWICE AS FAST. THE PATIENT WAS RECEIVING SUBCUTANEOUS LIDOCAINE INFUSIONS FOR CHRONIC PAIN. THE PATIENT HAD SHORT-TERM SYMPTOMS OF NAUSEA AND DIZZINESS LASTING 1-3 HOURS. THERE WERE NO LONG-TERM SEQUELAE PERTAINING TO INFUSION TREATMENTS. THE INFUSION PUMP WAS DISCONTINUED, AND THE PATIENT WAS TREATED WITH DIMENHYDRINATE/GRAVOL. THE PATIENT HAS IMPROVED AND IS ALSO RECEIVING INTERVENTIONAL PAIN TREATMENTS, INCLUDING FACET JOINT INJECTIONS AND NERVE BLOCKS. THE REPORTER ALSO STATES, ¿I THINK IN BOTH CASES PATIENTS DID NOT FOLLOW GUIDELINES AND PUMPS WERE EITHER SWADDLED IN WARM CLOTHING, INCREASING THE FLOW RATE, OR PUMPS WERE PLACED AT A LEVEL HIGHER THAN THE INFUSION SITE. WE HAVE NOW INCREASED THE SALINE ADDED TO LIDOCAINE FOR ALL OF OUR

  Patient problems: Dizziness; Nausea

  MAUDE report 16706639 ↗
• MalfunctionApr 10, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 2026095-2023-00046 FOR THE SECOND REPORT. FILL VOLUME: UNKNOWN. FLOW RATE: 5ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN SUBCUTANEOUS INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMPS SEEMED TO INFUSE TWICE AS FAST. THE PATIENT WAS RECEIVING SUBCUTANEOUS LIDOCAINE INFUSIONS FOR CHRONIC PAIN. THE PATIENT HAD SHORT-TERM SYMPTOMS OF NAUSEA AND DIZZINESS LASTING 1-3 HOURS. THERE WERE NO LONG-TERM SEQUELAE PERTAINING TO INFUSION TREATMENTS. THE INFUSION PUMP WAS DISCONTINUED, AND THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) FLUIDS AND DIMENHYDRINATE IV. THE PATIENT HAS CONGENITAL HEALTH PROBLEMS (KLIPPEL FEIL SYNDROME) AND STRUGGLES WITH PERSISTENT PAIN. THE PATIENT HAS HAD FOLLOW-UP TREATMENTS DONE WITH SUBCUTANEOUS LIDOCAINE AND HAD NO PROBLEMS. THE REPORTER ALSO STATES "I THINK IN BOTH CASES PATIENTS DID NOT FOLLOW GUIDELINES AND PUMPS WERE EITHER SWADDLED IN WARM CLOTHING, INCREASING THE FLOW RATE, OR PUMPS WERE PLACED AT A LEVEL HIGHER T

  Patient problems: Dizziness; Nausea

  MAUDE report 16706634 ↗

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