ambIT 220527Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857595005824), received between Oct 15, 2020 and Jun 2, 2021 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

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

• InjuryJun 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 10 ML EVERY 3 HOURS. PROCEDURE: FOOT FUSION PROCEDURE FOR LISFRANC (MIDFOOT) INJURY. CATHPLACE: UNKNOWN. DATE OF SURGERY: (B)(6) 2021. IT WAS REPORTED THE PATIENT FELT WEIRD AND WAS NOT ACTING 100% NORMAL. THE CALLER STATED, "THE SCREEN NOW SAYS 30 ML AND WHEN THEY LEFT THE HOSPITAL IT SAID 10." THE PATIENT EXPERIENCED ADDITIONAL SYMPTOMS WHICH INCLUDED BLURRED VISION, CONFUSION. THE PATIENT HAD PAUSED THE INFUSION ABOUT 10 MINUTES. THE PATIENT CALLED THE PHYSICIAN WHO TOLD THEM TO USE ORAL PAIN MEDICATIONS TO CONTROL PAIN BUT KEPT THE PUMP JUST IN CASE THE PAIN GOT AN TO UNCONTROLLABLE POINT. THE PUMP WAS TO INITIALLY BE DISCONTINUED.

  Patient problems: Blurred Vision; Confusion/ Disorientation

  MAUDE report 11922314 ↗
• MalfunctionOct 15, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 1000 ML , FLOW RATE: SETTINGS: LIMIT SET: 14ML DOSE: 8ML , DOSE TIME: 1 HOUR BOLUS: 6ML LOCKOUT TIME: 15-MINUTES , PROCEDURE: OUT-PATIENT TOTAL KNEE ARTHROSCOPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE CLINICIANS CONNECTED THE PUMP TO THE PATIENT AFTER REVIEWING THE PRE-PROGRAMED SETTINGS. AFTER PUSHING THE START BUTTON, THE CLINICIANS PUSHED FOR A BOLUS. AFTER SOME TIME ELAPSED (ABOUT AN HOUR), THE NURSE WENT TO INSTRUCT THE PATIENT AND FAMILY ON THE BOLUS AND THE PUMP BEGAN TO INFUSE. THE VOLUME INFUSED NOTED IT WAS 19.5ML AND THE NURSE STOPPED THE DEVICE, THINKING IT WAS INFUSING TOO MUCH. THEY REMOVED THE PUMP, AND REPLACED IT WITH ANOTHER THAT FUNCTIONED FINE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683321 ↗