ambIT* PIB IL v 1.5 220571Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494001384), received between May 17, 2023 and May 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K162165); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500 ML. FLOW RATE: 8ML/HR, BOLUS 6ML EVERY 20 MIN. PROCEDURE: ANTERIOR CRUCIATE LIGAMENT/MEDIAL COLLATERAL LIGAMENT (ACL/MCL) REPAIR. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2023. INFUSION STOP TIME: (B)(6) 2023. IT WAS REPORTED, THE AMBIT PUMP ¿SEEMED TO RUN OUT OF MEDS EARLY FRIDAY MORNING¿... ¿AMBIT RAN OUT AT 5AM ON 24TH-HAD ONLY PUSHED BUTTON 2X FOR EXTRA MEDS¿. DURING A PHONE CALL THE PATIENT STATED, ¿THE PUMP INFUSED TOO QUICKLY BUT I AM NOT REALLY SURE...I GUESS THAT WAS HOW THE DOCTOR PROGRAMMED THE PUMP....I JUST EXPECTED THE PUMP TO LAST LONGER¿. SHE REPORTED, SHE BELIEVED THE PUMP WAS STARTED AROUND 5PM THE DAY OF HER SURGERY ON (B)(6) 2023. THE PATIENT DENIED EXPERIENCING ANY ADVERSE SIDE EFFECTS: NO DIZZINESS, RINGING OF EARS, BLURRED VISION, METALLIC TASTE IN MOUTH, ETC. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162165. One submission often covers many models, so check the product and lot details in each record.

• Z-1688-2023 · Apr 24, 2023 · Terminated
  ambIT Cassette Filter Male Luer, Product Code: 220266
• Z-1685-2023 · Apr 24, 2023 · Terminated
  AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
• Z-1686-2023 · Apr 24, 2023 · Terminated
  SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
• Z-1684-2023 · Apr 24, 2023 · Terminated
  AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
• Z-1687-2023 · Apr 24, 2023 · Terminated
  SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568