LMA IPN924713Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704743541), received between Aug 2, 2022 and Jul 18, 2023 — classified as 2 injuries, 1 malfunction.

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

16 other recalls cover devices cleared under the same FDA submission (K090300); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE AUTOFUSER WAS SET TO 8ML PER HOUR AND THE AUTOFUSER EMPTIED COMPLETELY IN 24 HOURS. THE PATIENT HAD A WOUND VAC ON". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED STATED THAT THE "PATIENT WAS SOMNOLENT AFTER 24 HOURS OF INFUSION (500ML ROPIVACAINE INFUSED FROM AUTOFUSER IN THAT TIME PERIOD). 20% LIPIDS WERE ADMINISTERED (350ML) AND PATIENT'S MENTAL STATUS RETURNED TO BASELINE."

  Patient problems: Lethargy

  MAUDE report 17342613 ↗
• InjuryJul 18, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE AUTOFUSER WAS SET TO 10ML PER HOUR AND THE AUTOFUSER EMPTIED COMPLETELY IN 24 HOURS. THE PATIENT HAD A WOUND VAC ON". ADDITIONAL INFORMATION RECEIVED STATED THAT "THE PATIENT WAS LETHARGIC AND DIFFICULT TO AROUSE. LIPIDS WERE INFUSED TO COUNTERACT THE ROPIVACAINE AND THE PATIENT SEEMED TO RESPOND TO THIS. THE ISSUE WAS RESOLVED BY DISCONTINUING THE AUTOFUSER WITH ROPIVACAINE".

  Patient problems: Insufficient Information

  MAUDE report 17342416 ↗
• MalfunctionAug 2, 2022Disconnection; Leak/Splash; Disconnection; Leak/Splash

  COMPLAINT REPORTED THAT: "PUMP WAS HOOKED UP TO THE PATIENT AND WHILE PATIENT WAS STILL IN RECOVERY THE LINE BROKE AT THE CONNECTION POINT AND STARTED TO LEAK". NO PATIENT HARM REPORTED. NO REPORT OF MEDICAL INTERVENTION. PATIENT CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145197 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090300. One submission often covers many models, so check the product and lot details in each record.

• Z-0940-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0950-2019 · Oct 2, 2018 · Terminated
  AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0951-2019 · Oct 2, 2018 · Terminated
  AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
• Z-0941-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0955-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0946-2019 · Oct 2, 2018 · Terminated
  AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
• Z-0942-2019 · Oct 2, 2018 · Terminated
  AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
• Z-0954-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0943-2019 · Oct 2, 2018 · Terminated
  AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
• Z-0952-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0953-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0956-2019 · Oct 2, 2018 · Terminated
  AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0945-2019 · Oct 2, 2018 · Terminated
  AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
• Z-0948-2019 · Oct 2, 2018 · Terminated
  AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
• Z-0947-2019 · Oct 2, 2018 · Terminated
  AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

…and 1 more.