ambIT* PIB*IL Pump 220527Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00193494000769), received between Mar 10, 2023 and Jun 30, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Excess Flow or Over-Infusion

  FILL VOLUME: 70 ML. FLOW RATE/PROGRAMMED RATES: 15/30 AND A 4 ML BOLUS. PROCEDURE: NERVE BLOCK INFUSION POST KNEE REPLACEMENT SURGERY. CATHPLACE: UNKNOWN. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) THE FOLLOWING: INFUSION PUMP WAS DELIVERING AT INCORRECT (HIGHER) RATE DESPITE SETTINGS BEING PROGRAMMED CORRECTLY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2026 NOTED THE CLINICIANS IN THE POST-ANESTHESIA CARE UNIT (PACU) WERE CALLED TO GO CHECK ON THE PUMP FOR A PATIENT THAT WAS UPSTAIRS WORKING WITH PHYSICAL THERAPY (PT). THE CLINICIANS "WERE NO LONGER CARING FOR THE PATIENT SURGERY WAS THE DAY BEFORE. PT NOTICED THE PUMP WAS CONTINUOUSLY RUNNING AND WOULDN¿T STOP. THEY CALLED ANESTHESIA WHO THEN CALLED US TO EVALUATE."

  Patient problems: Insufficient Information

  MAUDE report 25664805 ↗
• MalfunctionMay 18, 2026Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2026-00041 FOR THE FIRST REPORT THE CUSTOMER REPORTED THAT FOLLOWING ANKLE SURGERY PERFORMED ON (B)(6) 2026, A PATIENT WAS DISCHARGED WITH AN AMBIT INFUSION PUMP CONNECTED TO A CATHETER SITE FOR POSTOPERATIVE LOCAL ANESTHETIC INFUSION THERAPY. THE PATIENT LATER REPORTED THAT APPROXIMATELY 300 ML OF LOCAL ANESTHETIC HAD INFUSED WITHIN APPROXIMATELY 12 HOURS AND SUBSEQUENTLY BECAME SYMPTOMATIC, POSSIBLY CONSISTENT WITH LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED, AND THE CATHETER WAS REMOVED IN THE FIELD. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APR-2026, REPORTING THAT THE PROGRAMMED SETTINGS FOR THE PUMP WERE: INITIAL LOADING DOSE 12 ML, DOSE 6 ML, INTERVAL 2 HOURS, BOLUS 3 ML, LOCKOUT TIME 30 MINUTES, AND 500 ML MEDICATION BAG. THE REPORTING PHYSICIAN INDICATED THE PATIENT MAY HAVE MISINTERPRETED THE PUMP DISPLAY RATHER THAN AN ACTUAL OVER-INFUSION OCCURRING.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 25209048 ↗
• MalfunctionMay 18, 2026Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2026-00044 FOR THE SECOND REPORT THE CUSTOMER REPORTED THAT FOLLOWING ANKLE SURGERY PERFORMED ON (B)(6) 2026, A PATIENT WAS DISCHARGED WITH AN AMBIT INFUSION PUMP CONNECTED TO A CATHETER SITE FOR POSTOPERATIVE LOCAL ANESTHETIC INFUSION THERAPY. THE PATIENT LATER REPORTED THAT APPROXIMATELY 300 ML OF LOCAL ANESTHETIC HAD INFUSED WITHIN APPROXIMATELY 12 HOURS AND SUBSEQUENTLY BECAME SYMPTOMATIC, POSSIBLY CONSISTENT WITH LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED, AND THE CATHETER WAS REMOVED IN THE FIELD. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL.ADDITIONAL INFORMATION WAS RECEIVED ON 24-APR-2026, REPORTING THAT THE PROGRAMMED SETTINGS FOR THE PUMP WERE: INITIAL LOADING DOSE 12 ML, DOSE 6 ML, INTERVAL 2 HOURS, BOLUS 3 ML, LOCKOUT TIME 30 MINUTES, AND 500 ML MEDICATION BAG. THE REPORTING PHYSICIAN INDICATED THE PATIENT MAY HAVE MISINTERPRETED THE PUMP DISPLAY RATHER THAN AN ACTUAL OVER-INFUSION OCCURRING.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 25209036 ↗
• MalfunctionMay 18, 2026Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED THAT AN AMBIT ELECTRONIC INFUSION PUMP WAS USED FOR POSTOPERATIVE PAIN MANAGEMENT FOLLOWING TREATMENT FOR MULTIPLE RIB FRACTURES. THE PUMP WAS INITIATED ON (B)(6) 2026 USING ROPIVACAINE HCL 0.2% WITH PROGRAMMED SETTINGS OF 12 ML EVERY 3 HOURS WITH OPTIONAL PATIENT BOLUS DOSING OF 3 ML EVERY 3 HOURS. ON (B)(6) 2026, THE PHYSICIAN¿S ASSISTANT IDENTIFIED A POSSIBLE FAST FLOW/OVERINFUSION CONDITION. THE PATIENT WAS ADMITTED/TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) FOR MONITORING. THE CUSTOMER REPORTED THE DEVICE HAD BEEN USED WITH AN ASSOCIATED AVANOS CATHETER/CONNECTION.

  Patient problems: Insufficient Information

  MAUDE report 25209008 ↗
• MalfunctionMar 5, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED, ON (B)(6) 2026 THE AMBIT PUMP DELIVERED 12.4 MILLILITERS FOR THE FIRST BOLUS, WHICH WAS HIGHER THAN EXPECTED. THE PATIENT WAS NOT INJURED, NO MEDICAL TREATMENT WAS REQUIRED, AND A REPLACEMENT PUMP WAS PROVIDED BEFORE DISCHARGE. THE AFFECTED PUMP WAS REMOVED FROM USE AND RETAINED AT THE SURGERY CENTER FOR RETURN AND EVALUATION. WHEN THE PROBLEM WAS NOTICED, THE DEVICE WAS IN USE FOR INITIAL THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524297 ↗
• MalfunctionJul 22, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: TOTAL SHOULDER CATH PLACE: UNKNOWN. IT WAS REPORTED THE PUMP DISPENSES TOO FREQUENTLY. "PUMP [WAS] PUT IN PAUSE MODE THEN TURNED OFF. PUMP TURNED BACK ON AND PROGRAM COMPARED TO ORDER." IT WAS RECOMMENDED TURNING PUMP OFF SINCE PATIENT REPORTS NUMBNESS INCREASING BUT CAUTIONED AGAINST LETTING ALL NUMBNESS RESOLVE."

  Patient problems: Numbness

  MAUDE report 22570979 ↗
• MalfunctionApr 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: TOTAL SHOULDER CATHPLACE: UNKNOWN IT WAS REPORTED THE USER "REMOVED THE CATHETER [ON (B)(6) 2025], EXPERIENCED LEAKING FROM CASSETTE. PATIENT REPORTED HE HAD HIS FANNY PACK ON ACROSS HIS CHEST AND IT WAS WET AND LEAKED UNTO HIS SKIN, CAUSING A SKIN REACTION...PATIENT ALREADY FOLLOWED [UP] WITH A PHYSICIAN REGARDING THE SKIN REACTION, AND HE STATED HE WILL SEND HIM A MEDICATED CREAM FOR HIS SKIN (NOT SURE WHAT MEDICATION)."

  Patient problems: Local Reaction

  MAUDE report 21807246 ↗
• MalfunctionNov 14, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ADDITIONAL INFORMATION RECEIVED 13-FEB-2025, PER THE CAREGIVER THE PATIENT "IS STILL IN THERAPY AND IS STILL USING SAME PUMP CURRENTLY. HAS NOT HAD ANY ISSUES WITH IT SINCE INITIAL CONTACT. STATES THAT ONCE THEY 'UNSTUCK' THE BUTTON, THE SAME ISSUE NEVER OCCURRED AGAIN, AND THEY HAVE NOT HAD ANY PROBLEMS WITH IT. HAVE NOT RETURNED DUE TO CONTINUED USE."

  Patient problems: Insufficient Information

  MAUDE report 20684133 ↗
• InjuryAug 15, 2024Cross Reactivity; Cross Reactivity

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN . PROCEDURE: ANKLE. CATHPLACE: UNKNOWN. 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 2026095-2024-00043 FOR THE FIRST EVENT. IT WAS REPORTED, DURING USE OF THE DEVICE THE PATIENT EXPERIENCED A METALLIC TASTE IN HIS MONTH. NO OTHER SYMPTOMS WERE REPORTED. THE PATIENT STATED THAT "HE CALLED THE ANESTHESIA NUMBER THAT WAS PRINTED ON HIS DISCHARGE INSTRUCTIONS, AND THAT HE SPOKE TO THE ANESTHESIA PERSON ON-CALL...THE PATIENT WAS ADVISED TO "TURN HIS PUMPS OFF, ESPECIALLY IF HE DEVELOPS OTHER SIGNS OF TOXICITY LIKE NUMBNESS IN THE MOUTH, RINGING IN THE EARS, DIZZINESS OR LIGHTHEADEDNESS, AND TO REACH BACK OUT TO ANESTHESIA." THE PATIENT WAS ADVISED "HE MAY NEED TO TAKE HIS OTHER PAIN MEDS AS PRESCRIBED IF HE TURNS THE PUMP OFF."

  Patient problems: Taste Disorder

  MAUDE report 19990709 ↗
• InjuryAug 15, 2024Cross Reactivity; Cross Reactivity

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN . PROCEDURE: ANKLE. CATHPLACE: UNKNOWN. 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 2026095-2024-00044 FOR THE SECOND EVENT. IT WAS REPORTED, DURING USE OF THE DEVICE THE PATIENT EXPERIENCED A METALLIC TASTE IN HIS MONTH. NO OTHER SYMPTOMS WERE REPORTED. THE PATIENT STATED THAT "HE CALLED THE ANESTHESIA NUMBER THAT WAS PRINTED ON HIS DISCHARGE INSTRUCTIONS, AND THAT HE SPOKE TO THE ANESTHESIA PERSON ON-CALL...THE PATIENT WAS ADVISED TO "TURN HIS PUMPS OFF, ESPECIALLY IF HE DEVELOPS OTHER SIGNS OF TOXICITY LIKE NUMBNESS IN THE MOUTH, RINGING IN THE EARS, DIZZINESS OR LIGHTHEADEDNESS, AND TO REACH BACK OUT TO ANESTHESIA." THE PATIENT WAS ADVISED "HE MAY NEED TO TAKE HIS OTHER PAIN MEDS AS PRESCRIBED IF HE TURNS THE PUMP OFF."

  Patient problems: Taste Disorder

  MAUDE report 19990692 ↗
• MalfunctionJul 17, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED, ¿PUMP WAS REPORTED TO HAVE INFUSED 40MLS (SUDDENLY). THE PATIENT WAS REPORTED TO BE EXHIBITING SYMPTOMS OF LOCAL ANESTHETIC TOXICITY. A LIPID RESCUE WAS ADMINISTERED. THE PATIENT IS FINE. THE SURGEON DID NOT THINK IT WAS LOCAL TOXICITY AS THE PATIENT RECEIVED MORE THAN 40MLS IN HIS PERIARTICULAR INJECTION IN THE SURGERY (TOTAL KNEE ARTHROPLASTY, TKA). I REVIEWED THE PUMP HISTORY (HX) AND THE PUMP SEEMED TO HAVE INFUSED CORRECTLY.¿

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19764704 ↗
• MalfunctionJul 17, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED, ¿THE PUMP WAS REPORTED TO BE GIVING MORE THAN THE BOLUS WAS PROGRAMMED. NO PATIENT ADVERSE EVENT WAS REPORTED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764653 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN . PROCEDURE: ELBOW. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT EXPERIENCED "DIZZINESS, NAUSEA AND BOWEL CHANGES FOR ABOUT 24-HOURS POST HAND, WRIST, ELBOW PROCEDURE ON (B)(6) 2024. [THE PATIENT] IS NOT TAKING OXYCODONE OR OTHER ORAL MEDICATION FOR ABOUT 24-HOURS. ADVISED [PATIENT] TO CLAMP OFF MEDICATION AND FOLLOW UP WITH ANESTHESIA FOR NEXT STEPS. 430 ML INFUSED THUS FAR. FOLLOWED UP WITH PATIENT. ANESTHESIA HAD HER DISCONTINUE PUMP."

  Patient problems: Dizziness; Nausea

  MAUDE report 19593425 ↗
• MalfunctionApr 28, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: 8ML/4ML. PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2023 AT 1349. INFUSION STOP TIME: (B)(6) 2023 AT 1620. IT WAS REPORTED, THE PUMP WAS STARTED AT 1349 AND BY 1620 HAD DELIVERED 112ML OF ANESTHETIC TO THE PATIENT; DURING PLACEMENT, THE NURSE CONFIRMED THE RX PUMP SETTINGS WERE CORRECT, (8ML AN HOUR WITH A 4ML BOLUS TIME OF 30 MIN). WHEN THE NURSE CHECKED ON THE PATIENT THEY NOTED THE PUMP WAS RUNNING CONTINUOUSLY; THE PUMP WAS REMOVED AND REPLACED, (BUT PAUSED UNTIL THE FOLLOWING DAY)- THE PATIENT WAS TO STAY OVERNIGHT FOR OBSERVATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20FEB2023 REPORTED, THE PATIENT WAS A PLANNED SAME DAY SURGERY; HOWEVER, WAS KEPT DUE TO PUMP AND RISK OF TOXICITY. THERE WERE NO SIGNS OF LOCAL ANESTHETIC TOXICITY (LSAT), THE PATIENT WAS PLACED ON TELE AND MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831958 ↗
• MalfunctionMar 10, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN ML. FLOW RATE: 8ML/4ML. PROCEDURE: TOTAL KNEE REPLACEMENT . CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2023. INFUSION STOP TIME: (B)(6) 2023. IT WAS REPORTED, THE PUMP WAS STARTED AT 1349 AND BY 1620 HAD DELIVERED 112ML OF ANESTHETIC TO THE PATIENT; DURING PLACEMENT, THE NURSE CONFIRMED THE RX PUMP SETTINGS WERE CORRECT, (8ML AN HOUR WITH A 4ML BOLUS TIME OF 30 MIN). WHEN THE NURSE CHECKED ON THE PATIENT THEY NOTED THE PUMP WAS RUNNING CONTINUOUSLY; THE PUMP WAS REMOVED AND REPLACED, (BUT PAUSED UNTIL THE FOLLOWING DAY)- THE PATIENT WAS TO STAY OVERNIGHT FOR OBSERVATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20FEB2023 REPORTED, THE PATIENT WAS A PLANNED SAME DAY SURGERY; HOWEVER, DUE TO THE PUMP AND THE RISK OF LOCAL ANESTHETIC TOXICITY (LAST), THEY WERE KEPT OVERNIGHT FOR OBSERVATION; THE PATIENT WAS PLACED ON TELE AND MONITORED, THERE WERE NO SIGNS OF (LSAT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520878 ↗

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-1688-2023 · Apr 24, 2023 · Terminated
  ambIT Cassette Filter Male Luer, Product Code: 220266
• Z-1686-2023 · Apr 24, 2023 · Terminated
  SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
• 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