ambIT* PIB-PCA v1.5 System w/Spike Filter Cass 220574Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494001308), received between Apr 9, 2024 and Apr 10, 2025 — classified as 4 malfunctions.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500ML, FLOW RATE: 4CC/HR, PROCEDURE: TOTAL LEFT KNEE, CATHPLACE: UNKNOWN. IT WAS REPORTED "WHEN PUMP WAS TURNED ON IT SHOWED 20. GAVE MEDICINE VERY QUICKLY AND ACTED LIKE IT WASN'T GOING TO STOP- WENT PAST 4 ML. TURNED OFF/ON, STILL RAN 'FAST', TRIED TO REPROGRAM. [S]TARTED AT 25. STILL GIVING MEDICINE 'FAST' AND NOT STOP. CHANGED PUMP." THE PATIENT WAS REPORTED TO BE DOING "GOOD." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822153 ↗
• MalfunctionDec 19, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: 15 ML/HR. PROCEDURE: TOTAL KNEE. CATHPLACE: UNKNOWN. IT WAS REPORTED THE NURSE REPORTED THE "PUMP [WAS] GIVING OVER BOLUS AMOUNT (PROGRAMMED FOR 15ML). WHEN DOSE REACHED 15 ML NURSE DISCONNECTED FROM PATIENT AND PUMP CONTINUED TO RUN UNTIL IT REACHED 20 ML. RECHECKED SETTINGS AND PROGRAMMED FOR 15 ML." THER WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20981824 ↗
• MalfunctionOct 16, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED VIA FDA MEDWATCH MEDSUN REPORT (B)(4), ¿THE (RN) SET UP AN AMBIT PERIPHERAL NERVE CATHETER PUMP FOR A PATIENT. THE PUMP WAS PROGRAMMED TO DELIVER AN INTERMITTENT BOLUS OF 8ML EVERY 2 HOURS. HOWEVER, AFTER THE INITIAL BOLUS WAS STARTED, THE PUMP MALFUNCTIONED AND WAS ABOUT TO ADMINISTER MORE THAN THE INTENDED DOSE. THE RN QUICKLY DISCONNECTED THE PUMP FROM THE PATIENT'S CATHETER AND OBSERVED THAT IT HAD REACHED 9.6ML BEFORE TURNING IT OFF. THE RN THEN DISCUSSED THE ISSUE WITH THE PRIMARY MEDICAL TEAM AND WAS INSTRUCTED TO USE EXISTING ORDERS AND OBTAIN A NEW AMBIT PUMP. THE INITIAL 8ML BOLUS WAS WASTED TO ENSURE THAT THE PATIENT DOES NOT RECEIVE A DOUBLE DOSE OF MEDICATION. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN;¿ THE INCIDENT OCCURRED IN MAY 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464324 ↗
• MalfunctionApr 9, 2024

  WHILE ATTEMPTING TO START AMBIT PUMP, THERE WAS ALREADY A BOLUS GIVEN WHICH HAD NOT BEEN PROGRAMMED INTO THE PUMP YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070460 ↗

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